Safe Biologics

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.”

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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.

Urges FDA to put patient safety first as draft guidance finalized

WASHINGTON, Feb. 9, 2012  — In response to the release of the U.S. Food and Drug Administration’s long-awaited draft guidance on the approval of biosimilar medicines in the United States, Dr. Dolinar, Chairman of the Alliance for Safe Biologic Medicines (ASBM) issued the following statement:

“We welcome the FDA’s draft guidance on biosimilar product development and approval as an important step forward in expanding access to existing biological therapies.

“Biological medicines are more complex than chemical drugs and highly sensitive to the manufacturing process in ways that could have health consequences for patients. Therefore FDA’s regulation of biosimilars appropriately takes into account these special aspects of biologics and the need to ensure patient safety in light of them. In order to do this, FDA appropriately focuses on the need for clinical trials for biosimilar medicines, and labels that provide data doctors need to treat their patients. However, FDA should also require unique names to distinguish every biologic medicine and facilitate effective traceability of these products.

“We look forward to working with the FDA to ensure that biosimilars are as safe and effective as the biologics currently on the market. When it comes to patient safety there can be no shortcuts.”

Biologics are made from living organisms and treat serious conditions including cancer, multiple sclerosis and diabetes. In 2010, the U.S. Congress authorized the FDA to develop a pathway to approve biosimilars, which are the nonidentical copies of biologic medicines. For more information or to speak with Dr. Dolinar, please email media@safebiologics.org.

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.

The Alliance for Safe Biologic Medicines provides factual information on biologic medications and advocates for policies that protect patient safety and ensure the accessibility of these products. More information available at www.safebiologics.org.