Issue Date: September 9, 2025
Issued by: Center for Biologics Evaluation and Research
Topic(s): Biosimilars
Status: Final
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry
This guidance describes the Agency’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). Additionally, this guidance is intended to provide recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing application for a proposed product submitted under section 351(k) of the PHS Act. This guidance finalizes and replaces the draft guidance of the same title issued on May 22, 2019, and replaces the final guidance “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product” issued on April 30, 2015.
Download the Guidance Document
