Safe Biologics

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

-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

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.

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. 

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.
 

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. 

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

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 

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.

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. 

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. 

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. 

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. 

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

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 

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.

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. 

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. 

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. 

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. 

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