2017-03-21 Interchangeability Comments

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CSRO Submits Interchangeability Comments to FDA

Posted: March 21, 2017

As patient and physician advocates, we have been deeply involved in the debate surrounding implementation of the Biologics Price Competition and Innovation Act (BPCIA). In response, the CSRO provided input on the FDA’s “Considerations in Demonstrating Interchangeability with a Reference Product: Guidance for Industry” (“guidance”).

Highlights 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.

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