Recently, the United States Food and Drug Administration (FDA) finalized additional questions and answers related to biosimilar development. The final guidance makes the second revision to the Questions and Answers on Biosimilar Development and the BPCI Act.
This update moved five questions from the draft guidance to the final guidance and updated seven other questions in the final guidance. Additionally, two questions in the draft guidance have been withdrawn.
The final guidance represents the FDA’s current thinking on the issue and does not establish any rights for any person and is not binding on the FDA or the public.
Additional Questions
The five added questions address sponsor responsibilities related to pediatric assessments for proposed biosimilar products; the types of information needed to support post approval manufacturing changes; clarifying that sponsors may not seek approval for a biosimilar with a different route of administration, dosage form, or strength than the reference product; provide clarity that biosimilars cannot be approved for conditions of use that have not previously been approved for the reference product; explain that sponsors should provide data and information to support the approval of a proposed biosimilar for an indication still covered by unexpired or orphan exclusivity (though the indication will not be approved until the orphan exclusivity expires).
Updated Questions
The seven questions that were updated in the guidance match the prior versions, with some minor editorial changes.
Withdrawn Questions
The withdrawn questions addressed: (1) a process for obtaining certain letters related to reference product access for testing for products with risk evaluation and mitigation strategy (REMS) with elements to assure safe use and (2) the definition of “protein” in Section 351(i)(1) of the PHS Act.
FDA plans to issue guidance that explains how the existing process for obtaining the letters for reference product access is being aligned with the framework set forth in the Further Consolidated Appropriations Act 2020.
Revised Draft Guidance
The FDA also revised the draft guidance to include just one question as to how sponsors can demonstrate that their proposed injectable biosimilar or interchangeable product has the same strength as the reference product.
The sole remaining draft question addresses how an applicant can demonstrate that its proposed injectable biosimilar product or proposed injectable interchangeable product has the same “strength” as the reference product.
Comments
Comments may be submitted on any guidance at any time per the Federal Register posting.