Biosimilar Development Must Rely on Science to Realize Patient Access and Savings Biosimilars Council Urges FDA Arthritis Advisory Committee

Patient access to biosimilars will hinge on critical policy decisions around extrapolation and biosimilar label content, asserts the Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA) in comments to the Food and Drug Administration (FDA) Arthritis Advisory Committee.

Christine Simmon, Senior Vice President, GPhA, and Executive Director, Biosimilars Council, is presenting in two public meetings on July 12-13 to the FDA Advisory Committee which is convening to discuss pending applications for two rheumatoid arthritis biosimilars.

“The Biosimilars Council commends the FDA’s work toward creating a regulatory environment that maximizes patient access to biosimilars,” said Simmon. “The Council is confident in the FDA’s robust and rigorous scientific approach to biosimilars and applauds the agency’s efforts to educate providers and patients so they can be confident in these medicines and access them at a lower cost.”

However, the Biosimilars Council believes that requiring a statement of biosimilarity on the product label, as proposed in FDA guidance, is unnecessary. The Council also supports extrapolation of data to confirm safety and efficacy. Simmon states:

“Including a biosimilar product’s biosimilarity data in addition to that of the reference product would only provide unnecessary information and create confusion for prescribers and patients. This differentiation between biosimilars and their reference products risks undermining the important provider education that is being done by the FDA today. Informing providers that ‘biosimilars have no clinically meaningful differences in terms of safety, purity and potency (safety and effectiveness) from the reference product,’ while requiring a differentiator in the labeling sends mixed signals to providers responsible for driving patient familiarity and comfort with these products.

…FDA has used comparability, or extrapolation of information, for nearly 20 years. In such cases, clinical data are typically provided to confirm safety and efficacy of one indication and, taking into account the totality of information gained from the comparability exercise. Based on the acceptable outcome of the comparability and clinical evaluations, the data may then be extrapolated to the other indications.”

“Policy decisions must be grounded in the reliable science used to develop these medicines. Decisions made now will create the market dynamic ultimately responsible for putting biosimilars and their savings within reach for millions of American patients,” said Simmon.