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Biosimilar Clinical Trials: How Can Regulators Determine Waiver Early In Development?

 
• By Derrick Gingery

The evidence is growing that comparative efficacy trials may not be necessary for all biosimilars, but regulators said they need a standard for sponsors to meet in order to waive them.

waiver
OTBB Director Sarah Yim said regulators need a framework for determining when comparative efficacy trials are necessary for biosimilar approval. • Source: Shutterstock

Regulators remain unsure what data would give them the confidence to waive biosimilar comparative efficacy trials early in development.

Amid evidence that clinical trials do not resolve many unanswered questions, calls are increasing for the requirement to be dropped

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