Both guidance documents aim to provide answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The 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 added by the BPCI Act.

The final guidance entitled ‘Questions and Answers on Biosimilar Development and the BPCI Act’ was announced in a Federal Register post published on 20 September 2021. The guidance revises the final guidance document entitled ‘Questions and Answers on Biosimilar Development and the BPCI Act’ issued 12 December 2018.

Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry
Date: September 2021
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-biosimilar-development-and-bpci-act-guidance-industry

Following stakeholder feedback, FDA has withdrawn three Q&As, and has, as appropriate, incorporated suggested changes to the Q&A.

The draft guidance entitled ‘New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)’ revises the draft guidance document entitled ‘New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)’, issued 12 December 2018 to retain appropriate Q&As in draft.

New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)
Date: September 2021
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/new-and-revised-draft-qas-biosimilar-development-and-bpci-act-revision-3

The two documents cover a wide variety of topics associated with development of biosimilars including meetings with FDA, formulation, delivery devices, drug-drug interactions, dosage forms for injectable biosimilars, as well as the ‘nature and type of information’ needed related to post-approval manufacturing changes for a licensed biosimilar.

Electronic or written comments on the two guidance documents can be submitted to the Dockets Management Staff under Docket FDA-2011-D-0611. This can be done via the website www.regulations.gov or written comments can be mailed to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All written/paper submission should be clearly marked and identified as Docket FDA-2011-D-0611.

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