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UK To Diverge On Biosimilar Data Requirements

Reduced Data Burden Welcome, But Industry Wants Global Approach

 
• By Ian Schofield

The UK regulator wants to be a “catalyst for change” in reducing regulatory burdens, saying that better regulation based on science is in everyone’s interest.

GUIDANCE CONCEPT
The MHRA is to issue new guidance on biosimilars • Source: Shutterstock

In a post-Brexit move towards regulatory divergence, the UK medicines agency, the MHRA, is about to issue a draft guideline that will reduce the UK clinical trial data requirements for biosimilar submissions.

MHRA head June Raine said the guideline, which would do away with the need for a comparative efficacy trial for biosimilars in most cases following the end of the Brexit transition period, would be issued for consultation in the coming weeks

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