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EMA: Should The Comparative Efficacy Requirement Be Waived For Biosimilars?

 
• By Ian Schofield

A concept paper drawn up by the EU medicines regulator says that revisiting the need for comparative efficacy trials is considered “the next important step” in keeping the biosimilar pathway attractive for developers. 

Clinical Trial New Vaccine Testing Medicine Drug 3d Illustration
Regulators are considering dropping comparative efficacy trial requirements for biosimilars • Source: Shutterstock

The European Medicines Agency is considering a more “tailored” approach to the assessment of new biosimilar medicines, with a focus on whether to waive the requirement for comparative efficacy studies when the biosimilar shows a high degree of similarity to the reference drug.

At present, the comparability exercise for biosimilars in the EU comprises the evaluation of quality data, in vitro and in vivo non-clinical data, and comparative

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