FDA Releases Draft Guidance on Comparative Analytical Assessment

May 22, 2019

Biosimilars Team

The Food and Drug Administration (FDA) has released a draft guidance titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.”

The draft guidance describes the Agency’s recommendations for the design and evaluation of comparative analytical studies to support a demonstration of biosimilarity between a proposed product and a reference product. It includes considerations for the development of a comparative analytical assessment plan using a stepwise approach. It also provides sponsors with recommendations on certain other aspects of the chemistry, manufacturing, and controls (CMC) portion of a marketing application for a proposed biosimilar product.

This draft guidance revises the guidance titled “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product,” which was published on April 30, 2015. In addition, it includes a section that serves to replace the draft guidance titled “Statistical Approaches to Evaluate Analytical Similarity,” which was withdrawn by the FDA in June 2018.

Electronic and written comments on this draft guidance are being accepted through July 22, 2019.