ASBM Comments Cited in Decision to Remove Biologic Medicines from NIOSH Hazardous Drugs List 

August 10, 2020

On July 30th, ASBM submitted comments on the National Institute for Occupational Safety and Health’s (NIOSH’s) proposed Hazardous Drugs List additions for 2020. (The original due date for comments had been June 30th, but the comment period was extended to July 30th.)

When the comment period was initially announced, several biologic medicines had been proposed- in ASBM’s view inappropriately- for inclusion on the 2020 NIOSH Proposed List of Hazardous Drugs in Healthcare Settings. These included the biologics trastuzumab and bevacizumab, widely used in cancer treatment.

Thankfully, when extending the deadline for comments, NIOSH indicated that trastuzumab and bevacizumab were no longer being considered for inclusion.

ASBM’s previous comments regarding the inclusion of monoclonal antibodies on the NIOSH list were among those cited in the Federal Register as the reason for the change:

Comment: Monoclonal antibodies (i.e., therapeutic proteins) are of such a large molecular weight that they do not pose a realistic risk to healthcare workers. For example, monoclonal antibodies ‘‘are too large to be absorbed through skin contact, and if ingested, they would be destroyed by digestion; if inhaled, the pulmonary system would prevent absorption. Consequently, these drugs are all administered by injection. The only potential risk to healthcare workers is of an accidental needle stick, which would not inject a pharmacologically active dose.’’

Accordingly, the monoclonal antibodies bevacizumab, blintumomab, and trastuzumab should not be placed on the List, and pertuzumab should be removed from [Table 1].

In ASBM’s comments, executive director Michael Reilly and Philip Schneider commended NIOSH for these revisions to the list:

The placement of these medicines on the NIOSH List would have compelled healthcare workers to take extraordinary precautions when handling and dispensing these drugs- including stringent facility, personal protective equipment, training, and waste disposal requirements specified in standards such as USP chapter <800>.

This would have imposed a significant burden on health care providers, imposing requirements for safe receipt, storage, preparation, and administration. These burdens would have increased health care costs unnecessarily and negatively affected access to these new, breakthrough therapies; such as by limiting which sites these critical medications are available and can be administered, such as infusion clinics and a physician’s office setting.

ASBM recognizes that balancing health care worker safety against health care cost impact and patient access is a complicated consideration in policy development, and we trust that NIOSH will continue to make good decisions as it attempts to strike the proper balance during its deliberations.

More information about the Proposed List of Hazardous Drugs may be found here. 

Read ASBM’s full comments here. 

ASBM Comments Cited in Decision to Remove Biologic Medicines from NIOSH Hazardous Drugs List

August 6, 2020

ASBM Comments Cited in Decision to Remove Biologic Medicines from NIOSH Hazardous Drugs List 

 

On July 30th, ASBM submitted comments on the National Institute for Occupational Safety and Health’s (NIOSH’s) proposed Hazardous Drugs List additions for 2020. (The original due date for comments had been June 30th, but the comment period was extended to July 30th.)

When the comment period was initially announced, several biologic medicines had been proposed- in ASBM’s view inappropriately- for inclusion on the 2020 NIOSH Proposed List of Hazardous Drugs in Healthcare Settings. These included the biologics trastuzumab and bevacizumab, widely used in cancer treatment.

 

Thankfully, when extending the deadline for comments, NIOSH indicated that trastuzumab and bevacizumab were no longer being considered for inclusion on the List.

ASBM’s previous comments regarding the inclusion of monoclonal antibodies on the NIOSH list were among those cited in the Federal Register as the reason for the change:

 

Comment: Monoclonal antibodies (i.e., therapeutic proteins) are of such a large molecular weight that they do not pose a realistic risk to healthcare workers. For example, monoclonal antibodies ‘‘are too large to be absorbed through skin contact, and if ingested, they would be destroyed by digestion; if inhaled, the pulmonary system would prevent absorption. Consequently, these drugs are all administered by injection. The only potential risk to healthcare workers is of an accidental needle stick, which would not inject a pharmacologically active dose.’’

Accordingly, the monoclonal antibodies bevacizumab, blintumomab, and trastuzumab should not be placed on the List, and pertuzumab should be removed from [Table 1].

 

In ASBM’s comments, executive director Michael Reilly and Philip Schneider commended NIOSH for these revisions to the list:

 

The placement of these medicines on the NIOSH List would have compelled healthcare workers to take extraordinary precautions when handling and dispensing these drugs- including stringent facility, personal protective equipment, training, and waste disposal requirements specified in standards such as USP chapter <800>.

This would have imposed a significant burden on health care providers, imposing requirements for safe receipt, storage, preparation, and administration. These burdens would have increased health care costs unnecessarily and negatively affected access to these new, breakthrough therapies; such as by limiting which sites these critical medications are available and can be administered, such as infusion clinics and a physician’s office setting.

ASBM recognizes that balancing health care worker safety against health care cost impact and patient access is a complicated consideration in policy development, and we trust that NIOSH will continue to make good decisions as it attempts to strike the proper balance during its deliberations.

More information about the Proposed List of Hazardous Drugs may be found here. 

 

Read ASBM’s full comments here. 

June 2020 Newsletter

July 1, 2020

Comment Period on NIOSH Hazardous Drugs List Extended to July 30th 

 

The National Institute for Occupational Safety and Health (NIOSH) has extended the comment period regarding its proposed Hazardous Drugs List additions for 2020. The comments on the proposed list are now due July 30th.

Several biologic medicines have been proposed- in ASBM’s view inappropriately- for inclusion on the 2020 NIOSH Proposed List of Hazardous Drugs in Healthcare Settings.

 

Drugs listed on this NIOSH list compel healthcare workers to take extraordinary precautions including stringent facility, personal protective equipment, training, and waste disposal requirements specified in standards such as USP chapter 800. This increases the cost of using drugs listed as hazardous substances, and may limit the sites at which these critical medications are available and can be administered such as infusion clinics and a physician’s office setting.

 

More information about the Proposed List of Hazardous Drugs may be found here. Comments may be submitted online here or mailed to:
NIOSH Docket Office
1090 Tusculum Avenue
MS-C34
Cincinnati, OH 45226-1998

Reference: Docket # CDC-2020-0046 and # NIOSH-233-C
 
 

ASBM Chair Featured in Webinar on Rebate Walls and Step Therapy

 

On June 24th, ASBM Chair Madelaine Feldman, MD, FACR, participated in a webinar on the topic of pharmaceutical rebate walls and step therapy. These policies and utilization management techniques used by pharmacy benefit managers (PBMs) often pose impediments to patients accessing the therapies they and their doctors have chosen.
The webinar was sponsored by the Coalition to Protect Patient Choice. In addition to Dr. Feldman, the event also featured a diverse group of speakers from the healthcare space, including:

-Robin Feldman, Professor, UC Hastings Law

 

-Steven Newark, Director of Policy and General Counsel, Global Healthy Living Foundation

 

-Jennifer Snow, VP for Reimbursement Policy, Xcenda, LLC

 

-Holly Vedova, Attorney Advisor to the Commissioner, Federal Trade Commission

“Biosimilars can provide substantial health and savings benefit to patients, but they may not be available to patients based on PBM policies and utilization management techniques. These practices interfere with the physician-patient relationship, and generally do not result in savings to the patient but rather, profit for the PBM.” said Dr. Feldman.

View the webinar presentations here.
Biosimilar Working Group Sends Letter to Manitoba Opposing Forced Substitution
In a letter dated June 18, the Canada-based Biosimilar Working Group (BWG) urged the Canadian province of Manitoba to reject the forced-substitution policies some provinces are implementing to increase biosimilar uptake. The letter was addressed to Cameron Friesen, Manitoba’s Minister of Health, Seniors, and Active Living.

From the letter:

 

We have concerns regarding implementation of any policies that would switch patients stable on an originator biologic medication to its biosimilar. We have strong medical reasons and unaddressed issues that underpin our thoughts and conclusions.

 

In your upcoming deliberations, we request full consultations with patient groups before you reach any conclusions. This way, policy can be forged in a manner that keeps Canadians safe, especially during this current pandemic and beyond. There can be no one-size-fits-all approach and developing policy with fulsome input from those who will be directly impacted will help achieve the desired outcomes effectively.

 

A recent report from INESSS, the Quebec health technology assessment body, concludes that there are certain populations on biologics for which very little or no data are available regarding the safety of biologics switching, and identifies significant concerns that clinicians have about non-medical switching. Most of the available scientific data have methodological limitations and raise significant uncertainties. Therefore, conducting adequate clinical studies with a larger number of individuals from these populations and greater homogeneity in the participants’ baseline characteristics would be useful for better determining the impact of switching between biologics.
The Biosimilars Working Group, of which ASBM is a member, is a key collaboration of diverse non-profit organizations, registered health charities, and healthcare advocacy coalitions who are dedicated to ensuring that good outcomes for patients are at the centre of health policy in Canada, specifically in the biologic medication treatment areas.

Read the full letter here.

Learn more about the Biosimilars Working Group here.

 

 
WHO Releases Executive Summary of WHO 70th INN Consultation

In June, the World Health Organization released an Executive Summary of its 70th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland on April 21st. ASBM presented virtually at this conference, represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

 

From the Executive Summary:
The Covid-19 pandemic highlights the leadership that WHO has in global health, and ASBM believes that this leadership is critical also for the naming of biosimilars, as it has repeatedly stated, especially as the number of biosimilars is increasing each year. It is also important to recognise that the biological qualifier (BQ) is still valid and that broad support for the BQ remains. The US FDA is supportive of unique identifiers for biologics and has instigated its own random 4-letter suffix. Health Canada (HC) has been a past supporter and is willing to harmonise, similarly the Australian TGA.

 

The ASBM noted that many other countries including Denmark, Japan and Jordan also support the BQ, while physicians are also supportive. However, despite this support, countries have developed their own systems but would have used a WHO system if WHO had moved ahead with the BQ.

 

The most common objection to a distinct suffix is that it implies biosimilars are inferior products and the US Federal Trade Commission (FTC) has raised the possibility that the current FDA naming system deters prescribers from using biosimilars, and impedes competition and price reduction. Some state pharmacists also feel that way. This false impression of inferiority has prompted two recent high-level meetings in Washington DC. The first was a joint FDA/FTC workshop, to address accusations that there had been disinformation to undermine physicians’ confidence in biosimilars, to address a perceived need for education on biosimilar safety, and a need to address patent regulation that has held back the use of biosimilars in the USA.

 

However, market share data suggest little, if any, lack of confidence in biosimilar use; for example, the market share of biosimilar ZARXIO (filgrastim-sndz) surpasses that of the reference product NEUPOGEN (filgrastim) in both the EU and the USA. So, the argument that the suffix creates a lack of confidence is false.

 

View ASBM’s presentation to the WHO INN Committee here:

Read the Executive Summary of the 70th INN Consultation here. 

 

 
ASBM Presents Poster on EU Physician Survey at DIA 2020 
From June 14-18, ASBM presented a poster abstract entitled “European Physician Perspectives on Biosimilars” at the DIA 2020 Global Annual Meeting, which was held virtually. ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP, who co-authored the poster, recorded a video walk-through of the poster which may be viewed here.

Data was drawn from the 2019 survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. This is also the first time the full survey findings have been made publicly available. Topics included physician perspectives on prescribing biosimilars, physician-led biosimilar substitution, third party substitution, adverse event reporting, and design of government tenders.

 

Among the survey’s key findings were that European physicians have increased their familiarity with biosimilars since last surveyed in 2013, but as their familarity increased, so has the importance of maintaining control of treatment decisions.

  • 82% consider maintaining physician control of treatment decisions to be very important or critical, representing a 10% increase from the 2013 survey.
  • Physicians are also highly uncomfortable with a non-medical substitution initiated by a third party. This figure has also increased sharply since the 2013 survey: 73% are uncomfortable with this, compared to 58% in 2013.
  • A strong majority (63%) consider it highly important for governments to make multiple therapeutic choices available in tenders, and a very strong majority (83%) believe these tenders should take into account factors besides price.

As with previous ASBM physician surveys, the European survey data will be the subject of a forthcoming article in the GaBI Journal, which will examine its results in even greater detail.

 

View the DIA 2020 poster here.

 

View Dr. Schneider’s video walkthrough here.
View the full European physician survey results here. 

 

 

 

 
ASBM Exhibits in BIO DIgital’s Virtual Patient Advocacy Pavilion 

 

From June 8-12, ASBM exhibited virtually as part of BIO Digital in the event’s Virtual Patient Advocacy Pavilion. ASBM’s online presence at the pavilion featured links to numerous resources on key biosimilar policy issues.

 

These included educational one-pagers on non-medical switching and automatic substitution; physician survey data from 13 countries, and recent whitepapers including “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, appearing in the June edition of GaBI Journal.
 

 
ASBM Presents E-Poster on European Rehumatologist Perspectives at EULAR E-Congress

 

On June 3rd, ASBM presented a poster abstract entitled “European Prescribers’ Perspectives on Biosimilars” at the 2020 Congress of the European League Against Rheumatism (EULAR), the group’s annual meeting, held virtually this year. The poster abstract’s authors were ASBM Chair Madelaine Feldman, MD, FACR; and executive director Michael Reilly.

 

The poster specifically highlighted rheumatologist perspectives, with data drawn ASBM’s 2019 survey of 579 European physicians in France, Germany, Italy, Spain, Switzerland, and the UK. Topics included physician attitudes on prescribing biosimilars, non-medical switching, and design of government tenders. Key findings included:

  • Rheumatologists were the most with familiar with biosimilars among the practice areas surveyed (99% familiar).
  • They had a higher than average comfort level prescribing biosimilars to new patients: 60% of rheumatologists were “very comfortable” doing so, while the average figure across the ten specialties surveyed was 34%.
  • Rheumatologists were also the least comfortable with a third party switching their patient for non-medical reasons (e.g. cost): 49% were “very uncomfortable” with this practice, compared to an average of 29% across all specialties.

View the EULAR 2020 poster here. 

 

 
UPCOMING EVENTS

 

World Drug Safety Congress 2020

Virtual – September 1-2, 2020

 

WHO 71st Consultation on International Nonproprietary Names

Geneva, Switerland – October 20-23, 2020

 

World Biosimilar Congress Europe 2020

Basel, Switzerland – November 3-5, 2020

 

June 2020 Newsletter

July 1, 2020

Comment Period on NIOSH Hazardous Drugs List Extended to July 30th 

 

The National Institute for Occupational Safety and Health (NIOSH) has extended the comment period regarding its proposed Hazardous Drugs List additions for 2020. The comments on the proposed list are now due July 30th.

Several biologic medicines have been proposed- in ASBM’s view inappropriately- for inclusion on the 2020 NIOSH Proposed List of Hazardous Drugs in Healthcare Settings.

 

Drugs listed on this NIOSH list compel healthcare workers to take extraordinary precautions including stringent facility, personal protective equipment, training, and waste disposal requirements specified in standards such as USP chapter 800. This increases the cost of using drugs listed as hazardous substances, and may limit the sites at which these critical medications are available and can be administered such as infusion clinics and a physician’s office setting.

 

More information about the Proposed List of Hazardous Drugs may be found here. Comments may be submitted online here or mailed to:
NIOSH Docket Office
1090 Tusculum Avenue
MS-C34
Cincinnati, OH 45226-1998

Reference: Docket # CDC-2020-0046 and # NIOSH-233-C
 
 

ASBM Chair Featured in Webinar on Rebate Walls and Step Therapy

 

On June 24th, ASBM Chair Madelaine Feldman, MD, FACR, participated in a webinar on the topic of pharmaceutical rebate walls and step therapy. These policies and utilization management techniques used by pharmacy benefit managers (PBMs) often pose impediments to patients accessing the therapies they and their doctors have chosen.
The webinar was sponsored by the Coalition to Protect Patient Choice. In addition to Dr. Feldman, the event also featured a diverse group of speakers from the healthcare space, including:

-Robin Feldman, Professor, UC Hastings Law

 

-Steven Newark, Director of Policy and General Counsel, Global Healthy Living Foundation

 

-Jennifer Snow, VP for Reimbursement Policy, Xcenda, LLC

 

-Holly Vedova, Attorney Advisor to the Commissioner, Federal Trade Commission

“Biosimilars can provide substantial health and savings benefit to patients, but they may not be available to patients based on PBM policies and utilization management techniques. These practices interfere with the physician-patient relationship, and generally do not result in savings to the patient but rather, profit for the PBM.” said Dr. Feldman.

View the webinar presentations here.
Biosimilar Working Group Sends Letter to Manitoba Opposing Forced Substitution
In a letter dated June 18, the Canada-based Biosimilar Working Group (BWG) urged the Canadian province of Manitoba to reject the forced-substitution policies some provinces are implementing to increase biosimilar uptake. The letter was addressed to Cameron Friesen, Manitoba’s Minister of Health, Seniors, and Active Living.

From the letter:

 

We have concerns regarding implementation of any policies that would switch patients stable on an originator biologic medication to its biosimilar. We have strong medical reasons and unaddressed issues that underpin our thoughts and conclusions.

 

In your upcoming deliberations, we request full consultations with patient groups before you reach any conclusions. This way, policy can be forged in a manner that keeps Canadians safe, especially during this current pandemic and beyond. There can be no one-size-fits-all approach and developing policy with fulsome input from those who will be directly impacted will help achieve the desired outcomes effectively.

 

A recent report from INESSS, the Quebec health technology assessment body, concludes that there are certain populations on biologics for which very little or no data are available regarding the safety of biologics switching, and identifies significant concerns that clinicians have about non-medical switching. Most of the available scientific data have methodological limitations and raise significant uncertainties. Therefore, conducting adequate clinical studies with a larger number of individuals from these populations and greater homogeneity in the participants’ baseline characteristics would be useful for better determining the impact of switching between biologics.
The Biosimilars Working Group, of which ASBM is a member, is a key collaboration of diverse non-profit organizations, registered health charities, and healthcare advocacy coalitions who are dedicated to ensuring that good outcomes for patients are at the centre of health policy in Canada, specifically in the biologic medication treatment areas.

Read the full letter here.

Learn more about the Biosimilars Working Group here.

 

 
WHO Releases Executive Summary of WHO 70th INN Consultation

In June, the World Health Organization released an Executive Summary of its 70th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland on April 21st. ASBM presented virtually at this conference, represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

 

From the Executive Summary:
The Covid-19 pandemic highlights the leadership that WHO has in global health, and ASBM believes that this leadership is critical also for the naming of biosimilars, as it has repeatedly stated, especially as the number of biosimilars is increasing each year. It is also important to recognise that the biological qualifier (BQ) is still valid and that broad support for the BQ remains. The US FDA is supportive of unique identifiers for biologics and has instigated its own random 4-letter suffix. Health Canada (HC) has been a past supporter and is willing to harmonise, similarly the Australian TGA.

 

The ASBM noted that many other countries including Denmark, Japan and Jordan also support the BQ, while physicians are also supportive. However, despite this support, countries have developed their own systems but would have used a WHO system if WHO had moved ahead with the BQ.

 

The most common objection to a distinct suffix is that it implies biosimilars are inferior products and the US Federal Trade Commission (FTC) has raised the possibility that the current FDA naming system deters prescribers from using biosimilars, and impedes competition and price reduction. Some state pharmacists also feel that way. This false impression of inferiority has prompted two recent high-level meetings in Washington DC. The first was a joint FDA/FTC workshop, to address accusations that there had been disinformation to undermine physicians’ confidence in biosimilars, to address a perceived need for education on biosimilar safety, and a need to address patent regulation that has held back the use of biosimilars in the USA.

 

However, market share data suggest little, if any, lack of confidence in biosimilar use; for example, the market share of biosimilar ZARXIO (filgrastim-sndz) surpasses that of the reference product NEUPOGEN (filgrastim) in both the EU and the USA. So, the argument that the suffix creates a lack of confidence is false.

 

View ASBM’s presentation to the WHO INN Committee here:

Read the Executive Summary of the 70th INN Consultation here. 

 

 
ASBM Presents Poster on EU Physician Survey at DIA 2020 
From June 14-18, ASBM presented a poster abstract entitled “European Physician Perspectives on Biosimilars” at the DIA 2020 Global Annual Meeting, which was held virtually. ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP, who co-authored the poster, recorded a video walk-through of the poster which may be viewed here.

Data was drawn from the 2019 survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. This is also the first time the full survey findings have been made publicly available. Topics included physician perspectives on prescribing biosimilars, physician-led biosimilar substitution, third party substitution, adverse event reporting, and design of government tenders.

 

Among the survey’s key findings were that European physicians have increased their familiarity with biosimilars since last surveyed in 2013, but as their familarity increased, so has the importance of maintaining control of treatment decisions.

  • 82% consider maintaining physician control of treatment decisions to be very important or critical, representing a 10% increase from the 2013 survey.
  • Physicians are also highly uncomfortable with a non-medical substitution initiated by a third party. This figure has also increased sharply since the 2013 survey: 73% are uncomfortable with this, compared to 58% in 2013.
  • A strong majority (63%) consider it highly important for governments to make multiple therapeutic choices available in tenders, and a very strong majority (83%) believe these tenders should take into account factors besides price.

As with previous ASBM physician surveys, the European survey data will be the subject of a forthcoming article in the GaBI Journal, which will examine its results in even greater detail.

 

View the DIA 2020 poster here.

 

View Dr. Schneider’s video walkthrough here.
View the full European physician survey results here. 

 

 

 

 
ASBM Exhibits in BIO DIgital’s Virtual Patient Advocacy Pavilion 

 

From June 8-12, ASBM exhibited virtually as part of BIO Digital in the event’s Virtual Patient Advocacy Pavilion. ASBM’s online presence at the pavilion featured links to numerous resources on key biosimilar policy issues.

 

These included educational one-pagers on non-medical switching and automatic substitution; physician survey data from 13 countries, and recent whitepapers including “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, appearing in the June edition of GaBI Journal.
 

 
ASBM Presents E-Poster on European Rehumatologist Perspectives at EULAR E-Congress

 

On June 3rd, ASBM presented a poster abstract entitled “European Prescribers’ Perspectives on Biosimilars” at the 2020 Congress of the European League Against Rheumatism (EULAR), the group’s annual meeting, held virtually this year. The poster abstract’s authors were ASBM Chair Madelaine Feldman, MD, FACR; and executive director Michael Reilly.

 

The poster specifically highlighted rheumatologist perspectives, with data drawn ASBM’s 2019 survey of 579 European physicians in France, Germany, Italy, Spain, Switzerland, and the UK. Topics included physician attitudes on prescribing biosimilars, non-medical switching, and design of government tenders. Key findings included:

  • Rheumatologists were the most with familiar with biosimilars among the practice areas surveyed (99% familiar).
  • They had a higher than average comfort level prescribing biosimilars to new patients: 60% of rheumatologists were “very comfortable” doing so, while the average figure across the ten specialties surveyed was 34%.
  • Rheumatologists were also the least comfortable with a third party switching their patient for non-medical reasons (e.g. cost): 49% were “very uncomfortable” with this practice, compared to an average of 29% across all specialties.

View the EULAR 2020 poster here. 

 

 
UPCOMING EVENTS

 

World Drug Safety Congress 2020

Virtual – September 1-2, 2020

 

WHO 71st Consultation on International Nonproprietary Names

Geneva, Switerland – October 20-23, 2020

 

World Biosimilar Congress Europe 2020

Basel, Switzerland – November 3-5, 2020

 

Biosimilar Working Group Sends Letter to Manitoba Opposing Forced Substitution

June 18, 2020

In a letter dated June 18, the Canada-based Biosimilar Working Group (BWG) urged the Canadian province of Manitoba to reject the forced-substitution policies some provinces are implementing to increase biosimilar uptake. The letter was addressed to Cameron Friesen, Manitoba’s Minister of Health, Seniors, and Active Living.

From the letter:

 

We have concerns regarding implementation of any policies that would switch patients stable on an originator biologic medication to its biosimilar. We have strong medical reasons and unaddressed issues that underpin our thoughts and conclusions.

 

In your upcoming deliberations, we request full consultations with patient groups before you reach any conclusions. This way, policy can be forged in a manner that keeps Canadians safe, especially during this current pandemic and beyond. There can be no one-size-fits-all approach and developing policy with fulsome input from those who will be directly impacted will help achieve the desired outcomes effectively.

 

A recent report from INESSS, the Quebec health technology assessment body, concludes that there are certain populations on biologics for which very little or no data are available regarding the safety of biologics switching, and identifies significant concerns that clinicians have about non-medical switching. Most of the available scientific data have methodological limitations and raise significant uncertainties. Therefore, conducting adequate clinical studies with a larger number of individuals from these populations and greater homogeneity in the participants’ baseline characteristics would be useful for better determining the impact of switching between biologics.
The Biosimilars Working Group, of which ASBM is a member, is a key collaboration of diverse non-profit organizations, registered health charities, and healthcare advocacy coalitions who are dedicated to ensuring that good outcomes for patients are at the centre of health policy in Canada, specifically in the biologic medication treatment areas.

Read the full letter here.

Learn more about the Biosimilars Working Group here.

ASBM Exhibits at Three Virtual Conferences in June

June 15, 2020

During the month of June, ASBM will be participating in three virtual conferences. We encourage all our members to visit the websites of these virtual conferences.asbmjune2020conferences

 

EULAR E-Congress (From June 3)

ASBM will present a poster abstract entitled “European Prescribers’ Perspectives on Biosimilars”. Data is drawn from ASBM’s 2019 survey of Rheumatologists in France, Germany, Italy, Spain, Switzerland, and the UK. Topics will include physician attitudes on prescribing biosimilars, non-medical switching, and design of government tenders.

 

More info here.

 

BIO Digital (June 8-12)

As part of BIO Digital’s Virtual Patient Advocacy Pavilion, ASBM will share educational literature on key biosimilar policy issues including non-medical switching and automatic substitution; physician survey data, and recent whitepapers including “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, appearing in in the June issue of GaBI Journal.

 

Learn more here.

 

DIA Global Meeting (June 14-18)

ASBM will present a poster abstract entitled “European Physician Perspectives on Biosimilars”, drawn from a 2019 survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. This is the first time the full survey results will be made publicly available.

 

Learn more about the DIA Global Meeting here.

ASBM Exhibits at Three Virtual Conferences in June

June 15, 2020

During the month of June, ASBM will be participating in three virtual conferences. We encourage all our members to visit the websites of these virtual conferences.asbmjune2020conferences

 

EULAR E-Congress (From June 3)

ASBM will present a poster abstract entitled “European Prescribers’ Perspectives on Biosimilars”. Data is drawn from ASBM’s 2019 survey of Rheumatologists in France, Germany, Italy, Spain, Switzerland, and the UK. Topics will include physician attitudes on prescribing biosimilars, non-medical switching, and design of government tenders.

 

More info here.

 

BIO Digital (June 8-12)

As part of BIO Digital’s Virtual Patient Advocacy Pavilion, ASBM will share educational literature on key biosimilar policy issues including non-medical switching and automatic substitution; physician survey data, and recent whitepapers including “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, appearing in in the June issue of GaBI Journal.

 

Learn more here.

 

DIA Global Meeting (June 14-18)

ASBM will present a poster abstract entitled “European Physician Perspectives on Biosimilars”, drawn from a 2019 survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. This is the first time the full survey results will be made publicly available.

 

Learn more about the DIA Global Meeting here.

ASBM Surveys Included in Systemic Review of Physician Biosimilar Perspectives

June 1, 2020

On May 5th, the British Medical Journal (BMJ) published a review of numerous surveys and studies examining physician attitudes toward biosimilars, entitled “Physicians’ perceptions of the uptake of biosimilars: a systematic review” Of 331 unique studies examined, only 23 met the quality assessment of two independent researchers for inclusion. Among these were several physician surveys conducted by ASBM. Most of the selected studies were conducted in Europe and commonly used short surveys. Key findings included:

  • Physicians’ familiarity with biosimilars varied: 49%–76% were familiar with biosimilars while 2%–25% did not know what biosimilars were, the percentages varying from study to study. Their measured knowledge was generally more limited compared with their self-assessed knowledge.
  • Physicians’ perceptions of biosimilars also varied: 54%–94% were confident prescribing biosimilars, while 65%–67% had concerns regarding these medicines.
  • Physicians seemed to prefer originator products to biosimilars for stable patients and prescribed biosimilars mainly for biologic-naive patients.
  • They considered cost savings and the lower price compared with the originator biologic medicine as the main advantages of biosimilars
  • Their doubts about biosimilars were often related to safety, efficacy and immunogenicity.
  • 64%–95% of physicians had negative perceptions of pharmacist-led substitution of biologic medicines.

Read the full study review and analysis here. 

April-May 2020 Newsletter

May 30, 2020

 
newsletter | April-May 2020
issue 88
 
 
 

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

 
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 
ASBM to Present at Virtual Conferences in June

 

During the month of June, ASBM will be participating in three virtual conferences. We encourage all our members to visit the websites of these virtual conferences.

 

EULAR E-Congress (From June 3)

ASBM will present a poster abstract entitled “European Prescribers’ Perspectives on Biosimilars”. Data is drawn from ASBM’s 2019 survey of Rheumatologists in France, Germany, Italy, Spain, Switzerland, and the UK. Topics will include physician attitudes on prescribing biosimilars, non-medical switching, and design of government tenders.

 

More info here.

 

BIO Digital (June 8-12)

As part of BIO Digital’s Virtual Patient Advocacy Pavillion, ASBM will share educational literature on key biosimilar policy issues including non-medical switching and automatic substitution; physician survey data, and recent whitepapers including “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, appearing in in the June issue of GaBI Journal.

 

Learn more here.

 

DIA Global Meeting (June 14-18)

ASBM will present a poster abstract entitled “European Physician Perspectives on Biosimilars”, drawn from a 2019 survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. This is the first time the full survey findings will be made publicly available.

 

Learn more about the DIA Global Meeting here.

 

 
Tufts Study: Lack of Preferred Coverage May be Hurting Biosimilars

 

On May 19th, a study was published in the Journal of the American Medical Association (JAMA) entitled “Coverage for Biosimilars vs Reference Products Among US Commercial Health Plans”. The study was conducted by investigators from the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center in Boston, Massachusetts. They evaluated 535 coverage decisions for biosimilars available in the United States in August 2019.

 

The study found that US health plans granted preferred status to biosimilars in just 14% of coverage decisions, according to a survey of decisions issued by 17 of the largest US commercial health plans, representing approximately 60% of commercially covered patients. By contrast, the reference product was given preferred status in 33% of decisions, and in 53% of decisions, neither the biosimilar nor the reference product was preferred.

 

“The slow uptake of biosimilars in the US has been attributed to factors such as patent disputes and reference product manufacturer tactics to delay biosimilar market entry. This study suggests that a lack of preferred coverage among health plans may also be delaying uptake”, said the study authors.

 

Read the study here. 

 

 
ASBM Surveys of Physician Perspectives on Biosimilars Included in Systemic Review

 

On May 5th, the British Medical Journal (BMJ) published a review of numerous surveys and studies examining physician attitudes toward biosimilars, entitled “Physicians’ perceptions of the uptake of biosimilars: a systematic review” Of 331 unique studies examined, only 23 met the quality assessment of two independent researchers for inclusion. Among these were several physician surveys conducted by ASBM. Most of the selected studies were conducted in Europe and commonly used short surveys. Key findings included:

  • Physicians’ familiarity with biosimilars varied: 49%–76% were familiar with biosimilars while 2%–25% did not know what biosimilars were, the percentages varying from study to study. Their measured knowledge was generally more limited compared with their self-assessed knowledge.
  • Physicians’ perceptions of biosimilars also varied: 54%–94% were confident prescribing biosimilars, while 65%–67% had concerns regarding these medicines.
  • Physicians seemed to prefer originator products to biosimilars for stable patients and prescribed biosimilars mainly for biologic-naive patients.
  • They considered cost savings and the lower price compared with the originator biologic medicine as the main advantages of biosimilars
  • Their doubts about biosimilars were often related to safety, efficacy and immunogenicity.
  • 64%–95% of physicians had negative perceptions of pharmacist-led substitution of biologic medicines.

Read the full study review and analysis here. 

 

 
Gastroenterologists: More Evidence Needed Before Non-Medical Switching of IBD Patients
On April 27th, the journal Digesitve Diseases and Sciences published a editorial by Frank I. Scott, MD entitled “Infliximab Versus Biosimilars for IBD: Is It Better to Fight Than Switch?. Dr. Scott heads the Crohn’s and Colitis Center, Division of Gastroenterology and Hepatology, Department of Medicine, at the University of Colorado.

 

In the editorial, Dr. Scott discusses a study appearing in the April issue of Digestive Diseases and Sciences which presents the most comprehensive review to date of data supporting non-medical switching between infliximab and CT-P13 (marketed as Inflectra).

 

Forty-nine randomized controlled trials, observational studies, and conference abstracts were included in the authors’ review. Of these, only three of the reviewed studies were randomized controlled trials, including NOR-SWITCH and two as-yet-unpublished IBD-specific trials. From the article:

 

Collectively, these studies demonstrated no significant difference in sustained clinical response between bio-originator infliximab and its biosimilars.

 

Despite these reassurances, significant questions remain regarding the long-term safety of non-medical switching strategies. While the summarized data in their review, for the most part, suggest that switching between bio-originator infliximab and CT-P13 is safe, the data quality is limited. As noted previously, only one randomized controlled trial has been published, with two additional studies included which are pending publication. Significant heterogeneity among existing observational studies limits their interpretation as well. Further, while non-medical switching policies have been enacted, there has been incomplete pharmacovigilance reporting on the patient level and pharmacoepidemiologic evaluation at the population level. Lastly, since the available data pertain to single switches from originator compound to CT-P13, they incompletely reflect the multi-directional switching that may occur in practice with non-medical switching.

 

Unfortunately, loss of response to therapies in both CD and UC is well described, obscuring the differentiation of loss of response due to expected rates versus that which can be attributed to the switch itself. Accurately measuring this risk will be vital in considering the true medical, ethical, and financial burdens related to non-medical switching. Further, it is unlikely that such risk–benefit balances are identical across different biologics, as accumulating data suggest that specific agents are preferable in UC versus CD and vice versa.

 

In conclusion, the review by [the authors] summarizes the current state of the evidence with regards to non-medical switching for bio-originator infliximab and CT-P13. While the totality of evidence appears reassuring, significant questions remain regarding the quality of and comparability of these data. Further prospective research is required before non-medical switching can be widely adopted, and long-term observation is requisite when it does occur to ensure the safety and effectiveness of such strategies.

 

Read the study here and the accompanying editorial here. 

 

 

 
ASBM Presents on Need for International Harmonization of Biologic Nomenclature at WHO 70th INN Consultation

On April 21st, ASBM presented to the World Health Organization’s (WHO’s) 70th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fourteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

 

Due to coronavirus-related travel restrictions in place at the time of the consultation, the presentation was made online for the first time.

 

While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary from the 69th INN Consultation – held on October 22, 2019 and in which ASBM also participated – may be viewed here. From the Executive Summary:

ASBM was of the opinion that the delay in implementing the biologic qualifier (BQ) was a result of opposition to it and reasoned that arguments for delay were baseless and nullified. It also contended that during this delay period, WHO was pressuring smaller regulators and proponents to drop support for the BQ despite the ASBM having addressed the main objections raised by opponents.

 

A great majority of US physicians already support the FDA 4-letter suffix with most of them also supporting the decision not to apply the suffix retrospectively. The ASBM also reported that at the DIA annual meeting in June 2019, an FDA representative identified enhancement of pharmacovigilance and safe use as major factors in implementing their suffix, alongside the inconsistent use of other identifiers such as the National Drug Code (NDC) number. According to the FDA, there should be adequate mechanisms in place to differentiate adverse events arising from reference or biosimilar products.

 

In a Canadian survey of 2017, only 20% of physicians recorded the non-proprietary name in patient records and only 1% of those identified the medicine using the Drug Identification Number. The ASBM also queried whether the INN Expert Group’s recommendation to WHO had changed, highlighting that neither the WHO Constitution nor Bylaws require unanimous consent of all stakeholders. It felt strongly that if WHO had moved to introduce the BQ many member states would have adopted it by now. Even in the EU, adverse event reporting data shows that a need remains for a specific non-proprietary biologics identifier, such as the BQ, despite reporting by brand name being required by law.

 

ASBM felt that broad support for the BQ remains amongst regulators and prescribers and urged the WHO to act now and adopt the BQ.

Read more about ASBM’s work on the issue of biologic naming here. 

 

Read the full Executive Summary of the 69th INN Consultation here. 

 

 
ASBM Submits Comments on FDA Draft Guidance for Communications Regarding Biosimilars

 

On April 6th, ASBM submitted comments on the FDA’s recently published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials.

 

It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.

 

The Draft Guidance is among the deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products.

 

ASBM’s comments reflected observations from ASBM Chair Madelaine Feldman, MD; Advisory Board Chair Philip Schneider MS, FASHP, FFIP; and Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association. From the comments:
One thing we’ve seen across Europe is that as more and more biosimilars are launched in a given product class, competition drives prices downward, discounts increase substantially, and biosimilar market share goes up. So we know what to expect, and what things to look for.

 

Thankfully we are seeing this happening in the US. Here we have a biosimilar filgrastim that launched with a relatively low 15% discount over its reference product. Today, with increased competition, that product has attained a majority share of the US market in its class with 55%. Late last year we saw the first rituximab biosimilar launch at a 10% discount over the reference product, and only a few months later the second launched at a larger, 24% discount.

 

We have every reason to believe this pattern will continue as we see it becoming routine for 3, 4, or 5 biosimilars approved for a reference product, and as these come on the market, manufacturers will continue to compete on price- moving from low discounts, to higher discounts.

 

ASBM representatives participated in a joint FDA/FTC Public Workshop held on March 9th at the FDA’s headquarters to discuss the guidance; as well as a related half-day event sponsored by the Hatch Center, Pfizer, and the Biosimilars Forum the following day, entitiled “Biosimilars: Breaking through the Barriers’.

 

Read ASBM’s comments in full here.

View all submitted comments here. 

 

 
UPCOMING EVENTS

 

EULAR E-Congress 2020

Congress.Eular.org  – June 3, 2020

 

BIO Digital Patient Advocacy Pavilion
https://www.bio.org/events/bio-digital – June 8-12, 2020

 

DIA Global Annual Meeting (Virtual)
DiaGlobal.org – June 14-18, 2020

 

DIA European Meeting 2020

Brussels, Belgium – June 30-July 3, 2020

 

World Drug Safety Congress 2020

Boston, MA – September 1-2, 2020

 

World Biosimilar Congress Europe 2020

Basel, Switzerland – November 3-5, 2020

 

April-May 2020 Newsletter

May 30, 2020

 
newsletter | April-May 2020
issue 88
 
 
 

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

 
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 
ASBM to Present at Virtual Conferences in June

 

During the month of June, ASBM will be participating in three virtual conferences. We encourage all our members to visit the websites of these virtual conferences.

 

EULAR E-Congress (From June 3)

ASBM will present a poster abstract entitled “European Prescribers’ Perspectives on Biosimilars”. Data is drawn from ASBM’s 2019 survey of Rheumatologists in France, Germany, Italy, Spain, Switzerland, and the UK. Topics will include physician attitudes on prescribing biosimilars, non-medical switching, and design of government tenders.

 

More info here.

 

BIO Digital (June 8-12)

As part of BIO Digital’s Virtual Patient Advocacy Pavillion, ASBM will share educational literature on key biosimilar policy issues including non-medical switching and automatic substitution; physician survey data, and recent whitepapers including “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, appearing in in the June issue of GaBI Journal.

 

Learn more here.

 

DIA Global Meeting (June 14-18)

ASBM will present a poster abstract entitled “European Physician Perspectives on Biosimilars”, drawn from a 2019 survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. This is the first time the full survey findings will be made publicly available.

 

Learn more about the DIA Global Meeting here.

 

 
Tufts Study: Lack of Preferred Coverage May be Hurting Biosimilars

 

On May 19th, a study was published in the Journal of the American Medical Association (JAMA) entitled “Coverage for Biosimilars vs Reference Products Among US Commercial Health Plans”. The study was conducted by investigators from the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center in Boston, Massachusetts. They evaluated 535 coverage decisions for biosimilars available in the United States in August 2019.

 

The study found that US health plans granted preferred status to biosimilars in just 14% of coverage decisions, according to a survey of decisions issued by 17 of the largest US commercial health plans, representing approximately 60% of commercially covered patients. By contrast, the reference product was given preferred status in 33% of decisions, and in 53% of decisions, neither the biosimilar nor the reference product was preferred.

 

“The slow uptake of biosimilars in the US has been attributed to factors such as patent disputes and reference product manufacturer tactics to delay biosimilar market entry. This study suggests that a lack of preferred coverage among health plans may also be delaying uptake”, said the study authors.

 

Read the study here. 

 

 
ASBM Surveys of Physician Perspectives on Biosimilars Included in Systemic Review

 

On May 5th, the British Medical Journal (BMJ) published a review of numerous surveys and studies examining physician attitudes toward biosimilars, entitled “Physicians’ perceptions of the uptake of biosimilars: a systematic review” Of 331 unique studies examined, only 23 met the quality assessment of two independent researchers for inclusion. Among these were several physician surveys conducted by ASBM. Most of the selected studies were conducted in Europe and commonly used short surveys. Key findings included:

  • Physicians’ familiarity with biosimilars varied: 49%–76% were familiar with biosimilars while 2%–25% did not know what biosimilars were, the percentages varying from study to study. Their measured knowledge was generally more limited compared with their self-assessed knowledge.
  • Physicians’ perceptions of biosimilars also varied: 54%–94% were confident prescribing biosimilars, while 65%–67% had concerns regarding these medicines.
  • Physicians seemed to prefer originator products to biosimilars for stable patients and prescribed biosimilars mainly for biologic-naive patients.
  • They considered cost savings and the lower price compared with the originator biologic medicine as the main advantages of biosimilars
  • Their doubts about biosimilars were often related to safety, efficacy and immunogenicity.
  • 64%–95% of physicians had negative perceptions of pharmacist-led substitution of biologic medicines.

Read the full study review and analysis here. 

 

 
Gastroenterologists: More Evidence Needed Before Non-Medical Switching of IBD Patients
On April 27th, the journal Digesitve Diseases and Sciences published a editorial by Frank I. Scott, MD entitled “Infliximab Versus Biosimilars for IBD: Is It Better to Fight Than Switch?. Dr. Scott heads the Crohn’s and Colitis Center, Division of Gastroenterology and Hepatology, Department of Medicine, at the University of Colorado.

 

In the editorial, Dr. Scott discusses a study appearing in the April issue of Digestive Diseases and Sciences which presents the most comprehensive review to date of data supporting non-medical switching between infliximab and CT-P13 (marketed as Inflectra).

 

Forty-nine randomized controlled trials, observational studies, and conference abstracts were included in the authors’ review. Of these, only three of the reviewed studies were randomized controlled trials, including NOR-SWITCH and two as-yet-unpublished IBD-specific trials. From the article:

 

Collectively, these studies demonstrated no significant difference in sustained clinical response between bio-originator infliximab and its biosimilars.

 

Despite these reassurances, significant questions remain regarding the long-term safety of non-medical switching strategies. While the summarized data in their review, for the most part, suggest that switching between bio-originator infliximab and CT-P13 is safe, the data quality is limited. As noted previously, only one randomized controlled trial has been published, with two additional studies included which are pending publication. Significant heterogeneity among existing observational studies limits their interpretation as well. Further, while non-medical switching policies have been enacted, there has been incomplete pharmacovigilance reporting on the patient level and pharmacoepidemiologic evaluation at the population level. Lastly, since the available data pertain to single switches from originator compound to CT-P13, they incompletely reflect the multi-directional switching that may occur in practice with non-medical switching.

 

Unfortunately, loss of response to therapies in both CD and UC is well described, obscuring the differentiation of loss of response due to expected rates versus that which can be attributed to the switch itself. Accurately measuring this risk will be vital in considering the true medical, ethical, and financial burdens related to non-medical switching. Further, it is unlikely that such risk–benefit balances are identical across different biologics, as accumulating data suggest that specific agents are preferable in UC versus CD and vice versa.

 

In conclusion, the review by [the authors] summarizes the current state of the evidence with regards to non-medical switching for bio-originator infliximab and CT-P13. While the totality of evidence appears reassuring, significant questions remain regarding the quality of and comparability of these data. Further prospective research is required before non-medical switching can be widely adopted, and long-term observation is requisite when it does occur to ensure the safety and effectiveness of such strategies.

 

Read the study here and the accompanying editorial here. 

 

 

 
ASBM Presents on Need for International Harmonization of Biologic Nomenclature at WHO 70th INN Consultation

On April 21st, ASBM presented to the World Health Organization’s (WHO’s) 70th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fourteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

 

Due to coronavirus-related travel restrictions in place at the time of the consultation, the presentation was made online for the first time.

 

While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary from the 69th INN Consultation – held on October 22, 2019 and in which ASBM also participated – may be viewed here. From the Executive Summary:

ASBM was of the opinion that the delay in implementing the biologic qualifier (BQ) was a result of opposition to it and reasoned that arguments for delay were baseless and nullified. It also contended that during this delay period, WHO was pressuring smaller regulators and proponents to drop support for the BQ despite the ASBM having addressed the main objections raised by opponents.

 

A great majority of US physicians already support the FDA 4-letter suffix with most of them also supporting the decision not to apply the suffix retrospectively. The ASBM also reported that at the DIA annual meeting in June 2019, an FDA representative identified enhancement of pharmacovigilance and safe use as major factors in implementing their suffix, alongside the inconsistent use of other identifiers such as the National Drug Code (NDC) number. According to the FDA, there should be adequate mechanisms in place to differentiate adverse events arising from reference or biosimilar products.

 

In a Canadian survey of 2017, only 20% of physicians recorded the non-proprietary name in patient records and only 1% of those identified the medicine using the Drug Identification Number. The ASBM also queried whether the INN Expert Group’s recommendation to WHO had changed, highlighting that neither the WHO Constitution nor Bylaws require unanimous consent of all stakeholders. It felt strongly that if WHO had moved to introduce the BQ many member states would have adopted it by now. Even in the EU, adverse event reporting data shows that a need remains for a specific non-proprietary biologics identifier, such as the BQ, despite reporting by brand name being required by law.

 

ASBM felt that broad support for the BQ remains amongst regulators and prescribers and urged the WHO to act now and adopt the BQ.

Read more about ASBM’s work on the issue of biologic naming here. 

 

Read the full Executive Summary of the 69th INN Consultation here. 

 

 
ASBM Submits Comments on FDA Draft Guidance for Communications Regarding Biosimilars

 

On April 6th, ASBM submitted comments on the FDA’s recently published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials.

 

It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.

 

The Draft Guidance is among the deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products.

 

ASBM’s comments reflected observations from ASBM Chair Madelaine Feldman, MD; Advisory Board Chair Philip Schneider MS, FASHP, FFIP; and Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association. From the comments:
One thing we’ve seen across Europe is that as more and more biosimilars are launched in a given product class, competition drives prices downward, discounts increase substantially, and biosimilar market share goes up. So we know what to expect, and what things to look for.

 

Thankfully we are seeing this happening in the US. Here we have a biosimilar filgrastim that launched with a relatively low 15% discount over its reference product. Today, with increased competition, that product has attained a majority share of the US market in its class with 55%. Late last year we saw the first rituximab biosimilar launch at a 10% discount over the reference product, and only a few months later the second launched at a larger, 24% discount.

 

We have every reason to believe this pattern will continue as we see it becoming routine for 3, 4, or 5 biosimilars approved for a reference product, and as these come on the market, manufacturers will continue to compete on price- moving from low discounts, to higher discounts.

 

ASBM representatives participated in a joint FDA/FTC Public Workshop held on March 9th at the FDA’s headquarters to discuss the guidance; as well as a related half-day event sponsored by the Hatch Center, Pfizer, and the Biosimilars Forum the following day, entitiled “Biosimilars: Breaking through the Barriers’.

 

Read ASBM’s comments in full here.

View all submitted comments here. 

 

 
UPCOMING EVENTS

 

EULAR E-Congress 2020

Congress.Eular.org  – June 3, 2020

 

BIO Digital Patient Advocacy Pavilion
https://www.bio.org/events/bio-digital – June 8-12, 2020

 

DIA Global Annual Meeting (Virtual)
DiaGlobal.org – June 14-18, 2020

 

DIA European Meeting 2020

Brussels, Belgium – June 30-July 3, 2020

 

World Drug Safety Congress 2020

Boston, MA – September 1-2, 2020

 

World Biosimilar Congress Europe 2020

Basel, Switzerland – November 3-5, 2020

 

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