FDA issues Draft Guidance for Industry on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations
FDA released Draft Guidance for Industry: “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations”. This draft guidance describes the Agency’s recommendations for the design and evaluation of comparative analytical studies, including considerations for the development of a comparative analytical assessment plan using a stepwise approach, to support a demonstration of biosimilarity. It also provides sponsors with recommendations on certain other aspects of the chemistry, manufacturing, and controls (CMC) portion of a marketing application for a proposed biosimilar product. The draft guidance is intended to assist applicants in demonstrating that a proposed product is biosimilar to a reference product under section 351(k) of the PHS Act.