Biologics

Guide on Biosimilar Postapproval Manufacturing Changes

FDA has released a final guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products — Questions and Answers.” The document explains how manufacturers should document and report changes to approved biosimilars, including changes involving manufacturing processes, production facilities, dosage forms and strengths.

Regarding information required for postapproval manufacturing changes, the guidance says manufacturers generally should conduct comparability assessments of prechange and postchange products, supported by analytical testing, stability data and, where appropriate, process validation. FDA also recognizes that comparisons with historical analytical data may be sufficient when product quality attributes remain comparable.

FDA says manufacturers do not generally need to include the original reference biologic in comparability testing. It recommends using a well-characterized in-house reference material alongside prechange and postchange biosimilar products. When manufacturers adequately demonstrate that the manufacturing change does not adversely affect quality, safety, efficacy or immunogenicity, FDA generally will not require additional reference materials.

If differences arise that cannot be adequately resolved through prechange/postchange comparisons, manufacturers may use analytical data from the original reference product submitted during initial biosimilar licensure to help justify comparability, it says.

Regarding whether biosimilars can be manufactured in facilities producing competing biosimilars or reference biologics, FDA says yes, but emphasizes the risks of cross-contamination and product mix-ups. Because the products may be highly similar, individual identity tests may not reliably distinguish them, it says. FDA therefore recommends additional manufacturing controls, including physical segregation where appropriate, personnel and material-flow controls, and procedures to prevent cross-contamination.

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