BRIEF—New FDA guidelines on biosimilarity

Draft guidance has been published on the US Food and Drug Administration’s (FDA) recommendations for the design and evaluation of comparative analytical studies for therapeutic protein biosimilars.

The agency has released the guidelines, entitled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations, to provide sponsors with recommendations on certain other aspects of the chemistry, manufacturing, and controls portion of a marketing application for a proposed biosimilar product.

Included in the guidelines are considerations for the development of a comparative analytical assessment plan using a stepwise approach, to support a demonstration of biosimilarity.

The draft guidance is intended to assist applicants in demonstrating that a proposed product is biosimilar to a reference product under section 351(k) of the PHS Act, and is a revision to guidelines published in 2015.