Draft Document Posts

The FDA Gets Moving (A Bit) on Biosimilar Guidance

Mark Crawford

On February 9 the U.S. Food and Drug Administration (FDA) released three draft guidance documents to assist biosimilar product development in the U.S.

The FDA guidance recommends a stepwise approach toward demonstrating biosimilarity that could ease trial requirements if biosimilarity can be demonstrated in earlier steps—such as a comparison between the proposed biosimilar and reference product on structure, function, animal toxicity, human pharmacokinetics and pharmacodynamics, clinical immunogenicity, and clinical safety and effectiveness.  (more…)