FDA Publishes Guidance on Therapeutic Protein Biosimilars

May 22, 2019

The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.

On May 21, 2019, FDA published guidance on the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act (PHS Act). The guidance also offers recommendations 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.

Among an overview of the PHS Act and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), the guidance specifically discusses expression systems, manufacturing processes, physicochemical properties, functional activities, target binding, impurities, reference products and standards, finished drug products, and stability. Considerations addressed for a comparative analytical assessment include reference and biosimilar products and data analysis.

The guidance is part of a series of documents to facilitate the implementation of the BPCI Act. Other guidance documents address scientific considerations, biosimilar development, clinical pharmacology data, labeling of biosimilars, and demonstrating interchangeability.

Source: FDA