New FDA Draft Guidance on Biosimilarity and Interchangeability



The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.”  According to the FDA, the draft guidance is “intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.”  The draft guidance provides the FDA’s responses on the following questions:

  • How may the applicant seek FDA review for licensure for an interchangeable biosimilar, and how does FDA intend to review an application submitted under section 351(k) that seeks licensure as an interchangeable biosimilar and includes data and information sufficient to support licensure of the product as a biosimilar product, but does not contain data and information sufficient to support licensure of the product as an interchangeable biosimilar?
  • How should a 351(a) BLA holder proceed if it seeks licensure of its biological product under section 351(k) as biosimilar to or interchangeable with another biological product licensed under section 351(a) (a “reference product”)?
  • Does FDA have recommendations for labeling of interchangeable biosimilars at this time?
  • Does FDA recommend that the BLA-holder of an approved interchangeable biosimilar include a labeling statement on interchangeability?

The draft guidance is to be published in the Federal Register on November 20, 2020.  Comments must be submitted within 60 days of its publication.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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