FDA finalizes more Q&As on biosimilar development

The US Food and Drug Administration (FDA) on Friday finalized additional questions and answers related to biosimilar development and the Biologics Price Competition and Innovation Act (BPCIA) and made minor revisions to several other questions within the document.

The final guidance is the second revision of a document first released in 2015. The agency maintains a separate draft guidance on the same subject and moves questions from the draft guidance to the final one once the questions are finalized. It also maintains a draft Q&A guidance on biosimilarity and interchangeability that was issued last November. (RELATED: FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics, Regulatory Focus 11 December 2018; FDA offers new Q&A on biosimilars and interchangeable products, Regulatory Focus 20 November 2020)

With this latest update, FDA has moved five questions from the draft guidance to the final one and updated seven others. The draft guidance has also been revised and contains just one question pertaining to how sponsors can demonstrate that their proposed injectable biosimilar or interchangeable product has the same strength as the reference product.

The five newly finalized questions address sponsors responsibilities related to pediatric assessments for proposed biosimilar products; the types of information are needed to support postapproval manufacturing changes; and clarifying that sponsors may not seek approval for a biosimilar with a different route of administration, dosage form, or strength than the reference product. The other two newly moved questions and answers provide clarification that biosimilars may not be approved for conditions of use that have not previously been approved for the reference product and explain that sponsors should provide data and information to support the approval of a proposed biosimilar for an indication that is still covered by unexpired orphan exclusivity, though the agency will not approve said indication until the orphan exclusivity expires.

The seven questions that have been updated or retained are largely the same as in previous versions of the guidance, with minor editorial changes throughout.

FDA

FDA finalizes more Q&As on biosimilar development

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