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FDA: Revised Q&A on Biosimilar Development

FDA: Revised Q&A on Biosimilar Development

On 17 September 2021, the US FDA released the revised Q&A Guidance on Biosimilar Development and the BPCI Act. The 28-page document provides rapid, development-related guidance to biosimilar and interchangeable biosimilar sponsors and other stakeholders on discrete issues.

The Rev2-document includes newly finalised Q&As on the submission of a supplement to an approved application for a biosimilar. This covers the nature and type of information a sponsor should provide to support a post-approval manufacturing change for a licensed biosimilar or interchangeable biosimilar.

Out of the ordinary and parallel to the revised Q&A (Rev2), the FDA has already released a draft of the upcoming Revision3 document. Therein, solely Question I.12 of the in 2018 released original version, which is missing in the current Rev2, is retained. It addresses how an applicant can demonstrate that its proposed injectable biosimilar product or proposed injectable interchangeable biosimilar product has the same “strength” as the reference product. The draft guidance does not include any other new Q&As or changes. The draft is currently open for comments.

These Q&A guidance documents are part of a series of guidance documents that FDA has developed to facilitate development of biosimilar and interchangeable biosimilar products and they are another step we’re taking to provide increased regulatory certainty and predictability for stakeholders.

FDA: Newly added guidance documents