Who We Are
The Alliance for Safe Biologic Medicines is an organization 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 the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
|Comment Period Open for MHRA Guidance on the Licensing of Biosimilar Products (UK)
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.
The new guidance is based on current EMA biosimilar guidance, with additional details about:
The consultation aims to get feedback from relevant stakeholders regarding the clarity and wording of the guidance, including any perceived contradictions or omissions.
Comments are being accepted until November 15, 2020. MHRA are hoping to finalise the guidance by the end of the year.
Read the new guidance here.
Submit your comments on the guidance here.
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:
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.
|ASBM Presents Poster at Biologics World Nordic 2020
On September 30th, ASBM Steering Committee member Andrew Spiegel, executive director of the Global Colon Cancer Association, presented virtually at the 3rd Annual Biologics World Nordic conference. Biologics World Nordic 2020 is the only conference in the Nordic region focused on biologic drugs and vaccines.
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:
“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.
|ASBM European Survey Published in Fall 2020 GaBI Journal
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:
|ASBM Campaign Educates on Non-Medical Switching in Canada, Contrasts with European Approach.
Throughout September, ASBM ran an extensive social media campaign on the topic of non-medical switching and forced biosimilar substitution, aimed at educating stakeholders in Canada about the practice with informative graphics and and supporting materials. These resources were made available both in English and in French.
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.
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
Download the factsheet “Biosimilar Substitution: What Can Canada Learn from the European Experience?”
Read the ASBM whitepaper on the European biosimilar markets.
|ASBM’S Schneider Chairs Pharmacovigilance Panel at World Drug Safety Congress USA 2020
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