💉FDA Guidance on Therapeutic Protein Biosimilars
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations." 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 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 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 This guidance finalizes and replaces the draft guidance of the same title issued on May 22, 2019, and replaces the final guidance "Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The guidance outlines compliance requirements for the development and marketing of therapeutic protein biosimilars, impacting businesses in the pharmaceutical industry. It specifies that companies must demonstrate biosimilarity to reference products, which will affect their regulatory strategies and product development timelines.