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US FDA Biosimilar Guidance Update Will Relax Interchangeability Standards

 
• By Cathy Kelly

Updated interchangeability guidance is one of several 'incremental reforms' agency is working on that could ease development burden for biosimilars, Commissioner Scott Gottlieb says.

Identical twins

The US FDA will make its draft requirements for demonstrating the interchangeability of biosimilars and their reference biologic less burdensome to help stimulate development of follow-on products, Commissioner Scott Gottlieb said at an April 19 policy conference sponsored by the Pharmaceutical Care Management Association.

The agency is working on a "suite of policies aimed at making incremental gains in trying to facilitate market entry...

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More from Biosimilars & Generics

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