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US FDA Unlikely To Issue Broad Biosimilar Guidance Saying Comparative Clinical Studies Unnecessary

 
• By Derrick Gingery

OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.

Insulin vials
Sarah Yim said extensive research helped convince hesitant colleagues that comparative clinical trials were not needed for insulin biosimilars. • Source: Alamy

An all-encompassing policy that biosimilars will not need comparative efficacy studies for approval seems unlikely for the US Food and Drug Administration, even as some officials continue to push in that direction.

Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, said the agency is taking a case-by-case approach, in part because internal

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