On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”  The draft guidance is designed to “provide[] answers to commonly asked questions from applicants and other interested parties . . . regarding postapproval manufacturing changes . . . made to licensed biosimilars and licensed interchangeable biosimilars.”

The draft guidance provides applicants with insight into the types of information and quality control data suggested to support a proposed postapproval manufacturing change, as well as identifying the relevant reporting categories and associated industry guidance.  The draft guidance categorizes post approval manufacturing changes as major, moderate, and minor (defined in the draft guidance as a change that has substantial, moderate, or minimal “potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as these factors may relate to the safety or effectiveness of the product,” respectively) and defines the corresponding reporting category.  The draft guidance provides further information on product data quality requirements for comparability studies demonstrating equivalence between pre- and post-change manufacturing, including appropriate reference materials.  The draft guidance makes particular note of the importance of comparability at intermediate manufacturing steps and in post-manufacturing storage settings, when applicable.

Lastly, the draft guidance addresses reporting standards when introducing a licensed biosimilar and/or licensed interchangeable biosimilar product into a multi-product manufacturing area or a multi-product contract manufacturing facility; or when supporting the approval of a supplement for a dosage form or a strength that has not previously been licensed under the 351(k) BLA, which the draft guidance notes is generally considered a major change.

The draft guidance is open for public comment until September 23, 2024.

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