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.
|ASBM Presents to Saudi Gastroenterology Association
On November 22nd and 29th, ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider presented to the Saudi Gastroenterology Association. The 45-minute presentation was livestreamed to gatherings of several hundred gastroenterologists in the three largest cities in Saudi Arabia: Riyadh, Jeddah, and Dammam. Entitled “Lessons from European Biosimilar Markets”, the presentation was based on the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons from Europe” published February 2020 in the GaBI Journal and coauthored by Reilly and Schneider.
The paper examined biosimilar substitution policies across Europe, looking for commonalities which led to successful and sustainable biosimilar markets. The analysis identified six principles the authors refer to as the “Gold Standard”:
The paper also identified three “Must-Haves” for a sustainable biosimilar market:
Read the whitepaper here.
FDA Issues Draft Guidance on Biosimilarity and Interchangeability
On November 19th, the US Food and Drug Administration (FDA) issued new Draft Guidance entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
These include how an applicant may seek FDA review for licensure for an interchangeable biosimilar, and how a 351(a) BLA holder should proceed if it seeks licensure of its biological product under section 351(k) as biosimilar to or interchangeable with another biological product licensed under section 351(a) (a “reference product”). In addition, the document discusses recommendations for labeling of interchangeable biosimilars.
When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development.
|US Biosimilar Market on Pace with Europe, says ASBM Chair at National Policy & Advocacy Virtual Summit on Biologics
On November 18, the Biologic Prescribers Collaborative, along with the Institute for Patient Access and the Alliance for Patient Access hosted its fifth annual National Policy & Virtual Summit on Biologics. As part of the Summit, ASBM Chair Madelaine Feldman, MD, FACR, was interviewed by AfPA’s Gavin Clingham about ASBM’s new whitepaper “US Biosimilars Market on Pace with Europe”; published in GaBI Journal. The paper is co-authored by Dr. Feldman along with ASBM’s Executive Director Michael Reilly.
As Dr. Feldman explains, the paper demonstrates FDA is moving at approximately the same pace as EMA based on the number of approvals at the same time after implementation of its regulatory pathway:
In addition, 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:
Watch Dr. Feldman’s interview here.
Read the full whitepaper here.
|ASBM Submits Comments on MHRA Guidance on the Licensing of Biosimilar Products (UK)
On November 15th, ASBM submitted comments on the United Kingdom’s Medicines and Healthcare products Regulatory Agency’s (MHRA’s) 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:
Among the elements addressed in ASBM’s comments was the language surrounding the need for comparative efficacy trials. The MHRA Guidance stated “In most cases, a comparative efficacy trial is not considered necessary.” From ASBM’s comments:
“In some cases, a comparative efficacy trial is not considered necessary”.
With regard to biosimilar substitution practices, however, MHRA’s guidance states:
The decision rests with the prescriber in consultation with the patient, who needs to be aware of the brand name of the product received. Substitution at the pharmacy level without consulting the prescriber is not permitted for biological medicines, including biosimilars.
Around the world, substitution decisions are largely handled at the local government level; in the US, the decision of whether a biosimilar is substitutable is made at the state level. In Canada, this decision is made at the provincial level, while within the European Union, the decision is made by individual Member States. ASBM believes that patients and their physician should remain in control of their treatment decisions, rather than an insurer, government, pharmacy, or other third party. We support MHRA’s position on the prohibition of automatic substitution.
Read the new guidance in full here.
Read ASBM’s comments on the guidance here.
|ASBM Exhibits at ACR Convergence 2020
On November 5th and 6th, ASBM exhibited virtually at American College of Rheumatology (ACR) Convergence 2020. The virtual conference took place ran from November 5 – 9, with dedicated exhibit hours on November 5th and 6th. More than 15,000 attendees from 106 countries attended the meeting.
ASBM’s virtual booth promoted recent ASBM whitepapers and posters, including a poster presented at the June 2020 EULAR E-Congress which drew from ASBM’s 2019 survey of rheumatologists across six Western European countries. Among the issues the survey covered are prescriber attitudes toward prescribing biosimilars to new patients, switching patients to biosimilars, and toward third party-initiated substitutions for nonmedical reasons. Key findings included:
Read more about ACR Convergence 2020 here.
View the EULAR 2020 poster here.
Saudi Gastroenterology Association Conference
Virtual – December 9, 2020
DIA Latin America Regulatory Conference
Virtual – February 22-23, 2021
World Biosimilar Congress USA 2021
Virtual – March 29-31, 2021