By: David Fazzolare
The long-awaited guidance on biosimilar product development has finally been released by FDA. On Thursday, February 9th, FDA released three guidance documents on biosimilar product development which reflect the agency’s current thinking on important scientific and regulatory considerations pertinent to submitting biosimilar applications.
The first guidance document, entitled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”, focuses on therapeutic protein products, and aims to help biosimilar applicants show that a biologic is biosimilar to a licensed biologic.
The second guidance document, entitled “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product”, details analytical considerations (e.g., biological characterization) involved in evaluating biosimilarity.
The third guidance document, entitled “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009”, addresses common questions biosimilar applicants may face in developing biosimilars, particularly in early product development stages.
FDA is expected to publish a request for public comments on the draft guidance documents in the Federal Register, and will consider such comments while finalizing its guidance.
Contact David A. Fazzolare for more information.