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Biosimilars: FDA Implementation

Since enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2010, we have been deeply involved with the Food and Drug Administration on implementation questions and issues. The CSRO has provided comments on every major FDA proposed guidance on this topic, including, most recently, the agency’s “Considerations in Demonstrating Interchangeability with a Reference Product: Guidance for Industry” (“guidance”).

Highlights of our comments on the guidance include:

  • We are concerned about FDA’s proposal to allow a sponsor who has established interchangeability for one indication to seek licensure as an interchangeable product for additional indications.
  • We urge the FDA to outline a minimum data package that would apply across all products. This would provide a “floor” for clinical studies on which FDA could build on a case-by-case basis, should the agency feel that additional data is required for a particular product or population.
  • At a minimum, we urge FDA to standardize immunogenicity testing of biosimilar agents across all disease conditions as well as control subjects.
  • We urge FDA to take a similarly cautious approach and require some clinical data for all indications especially when the pathophysiologic mechanisms involved in the diseases are clearly different.

The CSRO will continue to monitor all FDA proposals and activities related to implementation of the BPCIA, and will provide the agency with the perspective of the practicing rheumatologist on these policy decisions.