Capitol Hill Biosimilars Policy Forum Discusses Recent FDA Guidances

Washington, D.C. – The Alliance for Safe Biologic Medicines (ASBM), a national not-for-profit organization dedicated to ensuring patient safety and access to biologic medicines, partnered with Bloomberg Government to host “Biosimilars Policy Forum: Keeping Patients Safe” on February 27, 2012.

The event followed the release of the U.S. Food and Drug Administration’s long-awaited draft guidances on the approval of biosimilar medicines in the United States. Biosimilars are the imitative versions of existing biologic therapies whose patents have expired.

Panelists commented on the challenges and opportunities associated with the proposed guidelines and the science of these advanced medicines.

The panel was composed of the following speakers:

Brian Rye, Health-Care Financial Analyst with Bloomberg Government (moderator)
Dr. Richard Dolinar
, Chairman of the Alliance for Safe Biologic Medicines
Dr. David Charles
, Chief Medical Officer, Vanderbilt Neuroscience Institute, Chairman of the Alliance for Patient Access, and ASBM member partner
Seth Ginsberg
, Co-Founder and President of the Global Health Living Foundation, and ASBM member partner
Andrew Spiegel
, CEO and co-founder of the Colon Cancer Alliance, and ASBM member partner
Martha Raymond
, Patient Support Advocate, Colon Cancer Alliance
Jeffrey P. Kushan
, Partner, Sidley-Austin LLP

Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines, emphasized that patient safety must continue to preeminently guide regulatory decisions:

“Biologics are sophisticated medicines made from living cells and have highly intricate structures that are not easily understood, characterized or replicated.

The FDA must therefore approach the approval and designation of ‘interchangeability’ of a biosimilar on a case-by-case basis as a biosimilar is similar, but never identical, to innovator biologic.

Moreover, due to the organic nature of these medicines, a biologic and its biosimilar may change over time, diminishing the likeness of both products. This potential outcome – known as ‘product drift’ – must be considered.

To this end, patients and physicians should have the ability to carefully decide the best course of treatment. There should be no automatic substitution between an “interchangeable” biosimilar and its reference biologic without physician consent, or immediate notification at the time of the product substitution.

Lastly, unique names, clear product labels and other robust traceability measures must be implemented.

We appreciate the FDA’s important role in introducing biosimilars in the U.S. As the guidances are finalized, the Alliance will continue to serve as a resource for physicians, patients, lawmakers and regulators.”


About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.  We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond.