Classification Categories for Certain Supplements Under BsUFA III September 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-categories-certain-supplements-under-bsufa-iii?utm_medium=email&utm_source=govdelivery Today, the U.S. Food and Drug Administration issued two final guidances for industry related to biosimilar development. The final guidance “Classification Categories for Certain Supplements Under BsUFA III” provides recommendations for biosimilar manufacturers as well as FDA review staff on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications under section 351(k) of the Public Health Service Act (PHS Act). This draft guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted. This guidance finalizes and replaces the draft guidance of the same title issued on August 11, 2023. The publication of this guidance fulfills a commitment outlined in the Biosimilar User Fee Amendments of 2022 (BsUFA III) commitment letter. The final guidance for industry “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations” 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 under the 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. This guidance finalizes and replaces the draft guidance of the same title issued on May 22, 2019, and replaces the final guidance “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein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. These guidances will help maintain a predictable and efficient review process for biosimilars. Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry September 2025 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-therapeutic-protein-biosimilars-comparative-analytical-assessment-and-other-quality?utm_medium=email&utm_source=govdelivery