BioRationality: FDA Clarification Provides New Indications and Process Change for Biosimilars
Post-approval changes are categorized into three classes: annual record reporting for minor modifications, CBE-30 supplements for moderate changes, and PAS for significant changes. The FDA introduced a document in July 2024 to clarify biosimilar post-approval modifications, emphasizing thorough studies and comparability protocols. Changes to dosage form or strength require PAS, including comparability and CAA data. Biosimilars can change route of administration, formulation, and introduce new indications without filing as new drugs, supported by the potential passage of the S-150 Bill.
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Post-approval changes are categorized into three classes: annual record reporting for minor modifications, CBE-30 supplements for moderate changes, and PAS for significant changes. The FDA introduced a document in July 2024 to clarify biosimilar post-approval modifications, emphasizing thorough studies and comparability protocols. Changes to dosage form or strength require PAS, including comparability and CAA data. Biosimilars can change route of administration, formulation, and introduce new indications without filing as new drugs, supported by the potential passage of the S-150 Bill.