This month, FDA issued its new final guidance to replace a draft guidance that issued on May 22, 2019 titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry”. This final guidance outlines the FDA’s “recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product licensed under section 351(a) of the Public Health Service Act (PHS Act).” The guidance is also designed to provide recommendations to sponsors on the scientific and technical information for the CMC portion of a marketing application for a proposed product submitted under section 351(k) of the PHS Act.
