2:18 PM
Jul 12, 2018
 |  BC Extra  |  Politics & Policy

FDA to release biosimilars plan July 18

FDA’s Biosimilars Action Plan is likely to include elements the agency has disclosed in recent months that are intended to make reviews of biosimilars more predictable, reduce barriers to gaining approval of interchangeable biologics, and remove barriers to biosimilar competition.

The agency has not provided details of the plan, which is slated for release on July 18, but FDA Commissioner Scott Gottlieb tweeted on July 8 that the plan will include enhanced education for healthcare providers and patients, “reducing gaming that may delay market competition, strengthening [international] regulatory partnerships and providing clarity for product developers via guidance and meetings.”

Gottlieb said he will discuss the plan at a Brooking Institution event next Wednesday.

FDA has already signaled its intention to elevate the stature of biosimilars reviews. A proposed reorganization of the Office of New Drugs announced in June includes creation of a new Office of Therapeutic Biologics and Biosimilars (see “Getting Flatter”).

The office is intended to make the biosimilars review pathway more predictable. It will include policy staff who are likely to focus on practical steps such as creating standardized review templates and producing product-specific guidance documents.

FDA has taken steps to prevent branded drug companies from using REMS and distribution agreements to prevent generics companies from obtaining samples that are required for completing the ANDA process. The Biosimilars Action Plan is likely to try to tackle similar abuses that prevent biosimilars manufacturers from obtaining samples.

Gottlieb’s reference to international regulatory partnerships could signal an attempt to address a major impediment to biosimilars development, requirements to compare biosimilar products to reference products that have been licensed in the same jurisdiction. While FDA allows bridging studies for biosimilars, it requires a U.S.-licensed reference product for interchangeables. Bridging studies increase the cost of global biosimilar development programs, and according to biosimilars manufacturers may not be scientifically justified. Allowing the use of foreign-licensed reference products could dramatically reduce the cost of developing interchangeables.

The plan could lay out procedures for rewriting draft guidance on statistical methods for demonstrating biosimilarity to a reference product. FDA scrapped draft guidance on statistical methods in June following criticism from biosimilars developers (see “Biosimilars Do-over”).

The action plan is likely to include an announcement of plans for a public hearing to solicit recommendations for improving the regulation of biosimilars.

The plan could also solicit ideas for improving the utility of the Purple Book, a public list FDA maintains of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations.

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