FDA Issues Revised Guidance on Biosimilar Development and BPCIA

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for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft guidance entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act.”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?