Today (23 July,2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research have released comprehensive a draft guidance, "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products" addressing postapproval manufacturing changes for biosimilar and interchangeable biosimilar products.
Biosimilarity means that the biological product is highly similar to the reference product, with only minor differences in inactive components, and there are no clinically meaningful differences in safety, purity, or potency.
To achieve interchangeability, the applicant must:
Demonstrate biosimilarity;
Show that the product can be expected to produce the same clinical result as the reference product in any patient;
Ensure that for products administered more than once, the safety and efficacy risk of switching between the biosimilar and reference product is no greater than using the reference product alone.
The purpose of this guidance is to provide biologic product manufacturers with recommendations regarding the type of information they should provide FDA to support postapproval changes in manufacturing for licensed (approved) biosimilars and interchangeable biosimilars.
Also, this guidance aims to respond to frequently asked questions from applicants and other interested parties about postapproval manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars. This question-and-answer (Q&A) guidance is intended to inform prospective and current applicants of the types and nature of information applicants are required to provide as evidence of manufacturing changes for licensed biosimilars and licensed interchangeable biosimilars in different reporting categories.
The guidance categorizes manufacturing changes into three main types:
Major Changes (Prior Approval Supplement - PAS): Changes that have a substantial potential to impact product quality and require FDA approval before implementation.
Moderate Changes (Changes Being Effected in 30 Days - CBE-30): Changes that have a moderate potential to affect product quality and can be implemented 30 days after FDA notification.
Minor Changes (Annual Report - AR): Changes with minimal potential to affect product quality that can be documented in the annual report.
As part of its commitment to reauthorize the Biosimilar User Fee Act in 2022, the FDA is providing this draft guidance. For more detailed information, refer to the full guidance document and the FDA guidance page.
For further guidance and regulatory information, please refer to the provided links and stay updated with the latest FDA announcements.
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