Safe Biologics

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has opened a six-week consultation period on new guidance intended to help developers of biosimilars more clearly understand the requirements for biosimilar products in the UK.

• UK reference products
• the lack of requirement for in vivo studies in animals
• the changes in the requirement for a comparative efficacy trial in most cases

ASBM Chair Madelaine Feldman’s Term Extended

ASBM is pleased to announce that effective September 1st, the term of ASBM Chair Madelaine Feldman, MD, FACR, has been extended for an additional year. An ASBM chairman runs for a three-year period. ASBM Executive Director Michael Reilly, offered his praise for Dr. Feldman’s contributions to ASBM during her tenure:
“For the past three years, Dr. Feldman has been a dedicated and tireless advocate for patient-centered policies which increase access to biologic therapies, and keep treatment decisions between their patient and their physicians. Her knowledge and track record of leadership within the patient and physician community have proven invaluable to ASBM’s advocacy efforts, and we look forward to working with her in the upcoming year.”

Dr. Feldman began her term in September of 2017 and is ASBM’s third chairman since it was establishment in late 2010. ASBM’s inaugural chair Richard Dolinar, MD, served from 2011-2014 and was succeeded by Harry Gewanter, MD, MACR, who served from 2014-2017.

Mr. Spiegel’s video presentation consisted of three sections: patient perspectives on biosimilars, biosimilar substitution practices in Europe, and  physician perspectives on substitution:

First, he described the patient perspective on biologic medicines:
The patient community is excited about biosimilars. We’ve gone from one drug for colorectal cancer (CRC) to over a dozen in less than two decades; half of these are biologics. During that time, the life expectancy of late stage CRC patients has gone from months to years.This means more time with their families- meeting their grandchildren and attending the weddings of their children.

“Biosimilars offer many benefits to patients”, Spiegel explained, “including increased access to biologic therapies, and lower costs. As countries develop policies around biosimilars”, he continued, “we want to make sure these policies work for patients.”

One area of patient concern he identified is non-medical switching– where a patient is switched by private or government payers for reasons other than the patients health or safety- typically for cost reasons. “This has the potential to lessen the control a patient has over his or her condition, and most physicians do not support doing this,” he observed.

Spiegel supported this assertion with a poster based on data from ASBM’s 2019 survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries. For example, 73% percent of those surveyed stated they were uncomfortable with a third-party intiated switch made for non-medical reasons.

While permitted in a handful of countries (including the conference’s host country of Denmark), the automatic substitution of biologic medicines is extremely rare in Europe, observed Spiegel:

In nearly every European country, physicians and their patients are free to choose between a number of different biologics, and all the products are reimbursed. This competition drives down costs, and savings for the health system are achieved that way rather than through forced substitution.

View Mr. Spiegel’s video presentation here.

View or download the poster here. 

This month, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published Issue 3 of its 2020 print edition. This issue contains a whitepaper by ASBM’s Executive Director Michael Reilly and its Chair, Madelaine Feldman, MD, FACR; entitled “European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution”. The paper explores in detail the findings of ASBM’s survey of 579 prescribers of biologic medicines from 10 practice areas in 6 Western European countries.

Topics examined include physician perspectives on prescribing biosimilars, physician-led biosimilar substitution vs. third-party substitution, adverse event reporting, and design of government tenders.

As detailed in the paper, European physicians have increased their familiarity with biosimilars since last surveyed in 2013, but as their familarity increased, so too has the importance to them 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 too has 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.

Read the full whitepaper online here.
View a poster based on the findings here. 

British Columbia and Alberta have recently implemented, or begun implementing forced biosimilar switching policies,and other provinces are considering following suit. The controversial policy has drawn criticism from Canadian patient advocacy organizations including the Gastrointestinal Society, as well as the Canadian Association of Gastroenterology.

The British Columbia- and Alberta- style substitution policy stands in stark contrast to the approach taken by nearly every European country. The European approach is explored in great detail in the recent whitepaper published in GaBI Journal, “Policy recommendations for a sustainable biosimilars market: lessons from Europe”. The vast majority of European countries preserve physician/patient control of treatment decisions, reimburse multiple products, and control costs through competition rather than through forced substitution.
The campaign also highlights the strong opposition among European physicians to third-party substitution for non-medical reasons. (Notably, these sentiments are highly consistent with those of their Canadian counterparts, as revealed in ASBM’s 2017 survey of 403 Canadian physicians.)

Below are several ads used in the campaign. These are aimed at patients, physicans, and policymakers in Alberta, Ontario, and Quebec.

Ad —English patient groups
Ad —English health care practitioners
Ad —Ontario government decision-makers
Ad —French patient groups
Ad—French health care practitioners
Ad —French QC decision-makers
Ad —New Ontario government decision-makers
Click here to learn more about Biosimilar Substitution in Canada. 

Download the factsheet “Biosimilar Substitution: What Can Canada Learn from the European Experience?” 

Read the ASBM whitepaper on the European biosimilar markets.

On September 2nd, ASBM Advisory Board Chair Dr. Philip Schneider chaired a virtual panel discussion session on pharmacovigilance and distinct naming at the World Drug Safety Congress USA 2020. The program’s title was “Biosimilar risk assessment and pharmacovigilance.”

A key topic of the discussion was the greater emphasis on analytics in biosimilar approvals and decreasing emphasis on clinical trials. Biosimilars can also be approved, via extrapolation, for indications of the reference product for which they have undergone no clinical trials.

For this reason, the panelists were in agreement that post-marketing surveillance and the gathering of real-world data was important to biosimilar pharamcovigilance. They also agreed that ensuring accurate identification of biologics, including correct attribution of adverse events, was critical to these efforts.

Among the panelists was Dr. Raffaella Balocco, leader of the World Health Organization’s Expert Group on International Nonproprietary Names (INN). Following years of study on how to improve pharmacovigilance for biologic and biosimilar medicines, the INN Group offered its recommendation: the Biologic Qualifier (BQ).

The BQ is a four-letter suffix that would be appended to an INN shared by an originator biologic and all biosimilars. It would be a voluntary standard made available by the WHO to countries. Despite early and broad support from a number of countries, including the U.S., Canada, and Australia, the recommendation has not yet implemented by the WHO. The BQ was influential, however, on the development of the FDA’s four-letter suffix system, implemented in 2015.

Read more about the World Drug Safety Congress here. 

Read more about ASBM’s work with the WHO’s INN Group here. 

DIA Annual Canadian Meeting

Virtual – October 19-20, 2020

WHO 71st Consultation on International Nonproprietary Names

Geneva, Switzerland – October 20-23, 2020

World Biosimilar Congress Europe 2020

Virtual – November 3-5, 2020

ACR Convergence 2020

Virtual – November 6-11, 2020

www.NoForcedSwitching.ca

This controversial practice is rare among the advanced countries of the world, and has raised concerns among patient and physician organizations worldwide. In nearly every European country, for example, patients and physicians are free to choose the most suitable product, and while new patients are encouraged to try the lowest cost medicine first, the treatment decision ultimately rests with the physician and patient. All products are reimbursed, and automatic or forced substitution is not practiced.

The microsite contains a variety of materials, including:

• National and province-specific news stories about how provinces have implemented, or are considering such policies.
• Statements from physician societies and patient advocacy organizations raising concerns with the practice
• Fact sheets contrasting the forced-substitution policies of British Columbia and Alberta with the pro-competition policies of European countries
• Surveys showing strong physician opposition to third-party non-medical substitutions from physicians in Europe and Canada
• A whitepaper showing how European countries achieve biosimilar savings by preserving- not limiting- physician and patient choice
• Shareable social media graphics
• The ability for Canadians to quickly send a message to your Health Minister expressing your opposition to forced substitution in their province

We encourage you to take a moment to visit: www.noforcedswitching.ca

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has opened a six-week consultation period on new guidanceintended to help developers of biosimilars more clearly understand the requirements for biosimilar products in the UK.

• UK reference products
• the lack of requirement for in vivo studies in animals
• the changes in the requirement for a comparative efficacy trial in most cases

Public Webinar on Final PMPRB Guidelines November 20th

Canada’s PMPRB will be hosting a public webinar to discuss its’ recently-recently-finalized drug pricing Guidelines and address questions. Originally scheduled to take place on November 10th, the webinar has been re-scheduled to November 20th, from 1:30PM to 2:30PM (EST).

The link for the webinar can be accessed from the PMPRB’s  Guidelines Home Page. No registration is required to join the webinar.

Next month, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) will publish Issue 4 of its 2020 print edition. The issue will contain a whitepaper entitled “US biosimilars marketplace on pace with Europe”. The article is co-authored by ASBM’s Executive Director Michael Reilly and its Chair, Madelaine Feldman, MD, FACR.

The paper will explores in detail the considerable successes of the U.S. biosimilar pathway in its first 10 years, including the approval of 28 biosimilars and launch of 18 of these in just over five years’ time. In addition, the paper will examine how competition between multiple biosimilars are increasingly leading to lower prices and greater biosimilar market share. From the paper:

In the US, biosimilars have gained significant share in the majority of therapeutic areas in which they have been introduced, ranging on average from 20% to 25% within the first year of launch, with some projected to reach greater than 50% within the first 2 years. As expected, first-to-market biosimilars tend to capture a greater portion of the segment compared to later entrants. Filgrastim biosimilars have been on the market the longest at 5 years and have achieved a 72% share, while bevacizumab and trastuzumab biosimilars have approximately 40% share. Rituximab and infliximab have had the most limited adoption, with approximately 20% market share.

The paper may be viewed online at Gabi’s website here.  

On November 18, the Biologic Prescribers Collaborative, along with the Institute for Patient Access and the Alliance for Patient Access will co-host its fifth annual National Policy & Virtual Summit on Biologics.

The event will run 11:30 a.m. to 2 p.m. EDT, Wednesday, November 18.

Click here to register for the event.

ASBM Presents at WHO’s 71st INN Consultation 

On October 20th, ASBM presented to the World Health Organization’s (WHO’s) 71st Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fifteenth 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.

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June.  In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
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 70th INN Consultation – held on April 21, 2020 and in which ASBM also participated – may be viewed here. 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 system but would have used a WHO system if WHO had moved ahead with the BQ.

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

Read more about ASBM’s work with the WHO’s INN Group here. 

Missed last month’s ASBM Newsletter?

Read it Here. 

DIA Latin America Pharmacovigilance and Risk Management Strategies Workshop
Virtual – Nov 11-12, 2020

National Policy & Advocacy Virtual Summit on Biologics

Virtual – November 18, 2020

Saudi Gastroenterology Association Conference

Virtual – November 22, 29, 2020

www.NoForcedSwitching.ca

This controversial practice is rare among the advanced countries of the world, and has raised concerns among patient and physician organizations worldwide. In nearly every European country, for example, patients and physicians are free to choose the most suitable product, and while new patients are encouraged to try the lowest cost medicine first, the treatment decision ultimately rests with the physician and patient. All products are reimbursed, and automatic or forced substitution is not practiced.

The microsite contains a variety of materials, including:

• National and province-specific news stories about how provinces have implemented, or are considering such policies.
• Statements from physician societies and patient advocacy organizations raising concerns with the practice
• Fact sheets contrasting the forced-substitution policies of British Columbia and Alberta with the pro-competition policies of European countries
• Surveys showing strong physician opposition to third-party non-medical substitutions from physicians in Europe and Canada
• A whitepaper showing how European countries achieve biosimilar savings by preserving- not limiting- physician and patient choice
• Shareable social media graphics
• The ability for Canadians to quickly send a message to your Health Minister expressing your opposition to forced substitution in their province

We encourage you to take a moment to visit: www.noforcedswitching.ca

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has opened a six-week consultation period on new guidanceintended to help developers of biosimilars more clearly understand the requirements for biosimilar products in the UK.

• UK reference products
• the lack of requirement for in vivo studies in animals
• the changes in the requirement for a comparative efficacy trial in most cases

Public Webinar on Final PMPRB Guidelines November 20th

Canada’s PMPRB will be hosting a public webinar to discuss its’ recently-recently-finalized drug pricing Guidelines and address questions. Originally scheduled to take place on November 10th, the webinar has been re-scheduled to November 20th, from 1:30PM to 2:30PM (EST).

The link for the webinar can be accessed from the PMPRB’s  Guidelines Home Page. No registration is required to join the webinar.

Next month, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) will publish Issue 4 of its 2020 print edition. The issue will contain a whitepaper entitled “US biosimilars marketplace on pace with Europe”. The article is co-authored by ASBM’s Executive Director Michael Reilly and its Chair, Madelaine Feldman, MD, FACR.

The paper will explores in detail the considerable successes of the U.S. biosimilar pathway in its first 10 years, including the approval of 28 biosimilars and launch of 18 of these in just over five years’ time. In addition, the paper will examine how competition between multiple biosimilars are increasingly leading to lower prices and greater biosimilar market share. From the paper:

In the US, biosimilars have gained significant share in the majority of therapeutic areas in which they have been introduced, ranging on average from 20% to 25% within the first year of launch, with some projected to reach greater than 50% within the first 2 years. As expected, first-to-market biosimilars tend to capture a greater portion of the segment compared to later entrants. Filgrastim biosimilars have been on the market the longest at 5 years and have achieved a 72% share, while bevacizumab and trastuzumab biosimilars have approximately 40% share. Rituximab and infliximab have had the most limited adoption, with approximately 20% market share.

The paper may be viewed online at Gabi’s website here.  

On November 18, the Biologic Prescribers Collaborative, along with the Institute for Patient Access and the Alliance for Patient Access will co-host its fifth annual National Policy & Virtual Summit on Biologics.

The event will run 11:30 a.m. to 2 p.m. EDT, Wednesday, November 18.

Click here to register for the event.

ASBM Presents at WHO’s 71st INN Consultation 

On October 20th, ASBM presented to the World Health Organization’s (WHO’s) 71st Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fifteenth 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.

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June.  In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
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 70th INN Consultation – held on April 21, 2020 and in which ASBM also participated – may be viewed here. 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 system but would have used a WHO system if WHO had moved ahead with the BQ.

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

Read more about ASBM’s work with the WHO’s INN Group here. 

Missed last month’s ASBM Newsletter?

Read it Here. 

DIA Latin America Pharmacovigilance and Risk Management Strategies Workshop
Virtual – Nov 11-12, 2020

National Policy & Advocacy Virtual Summit on Biologics

Virtual – November 18, 2020

Saudi Gastroenterology Association Conference

Virtual – November 22, 29, 2020