FDA Issues Revised Guidance on Biosimilar Development and BPCIA

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On September 20, 2021, the FDA issued a revised final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft guidance entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act.” According to FDA, the guidance documents “provide[] answers to common questions from prospective applicants and other interested parties regarding the [BPCIA]” and “[t]he question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and interchangeable biosimilars, as well as describe FDA’s interpretation of certain statutory requirements . . .”

In addition to revising and withdrawing certain Q&As, the FDA finalized its answers to the following questions:

  • Q.I.16. How can a proposed biosimilar product applicant fulfill the requirement for pediatric assessments or investigations under PREA?
  • Q.I.20. What is the nature and type of information that a sponsor should provide to support a postapproval manufacturing change for a licensed biosimilar product?
  • Q.I.21. May a sponsor seek approval, in a 351(k) application or a supplement to an approved 351(k) BLA, of a route of administration, a dosage form, or a strength that is different from that of the reference product?
  • Q.I.22. May a sponsor seek approval, in a 351(k) application or a supplement to an approved 351(k) BLA, for a condition of use that has not previously been approved for the reference product?
  • Q.I.24. May an applicant submit data and information to support approval of a proposed biosimilar or interchangeable product for an indication for which the reference product has unexpired orphan exclusivity?

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. Attorney Advertising.

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