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UK Could Become ‘World Leader’ On Biosimilar Regulation

Country’s Reduced-Data Pathway Could Be Followed By EU And US

 
• By Dave Wallace

The UK is putting itself in a position to play a leading role in global biosimilars regulation, thanks to a proposed new registration pathway that will not require comparative efficacy data, delegates to a Westminster Health Forum online conference heard earlier today.

UK flag world map
The UK is poised to play a leading role on the global biosimilars stage • Source: Alamy

A new streamlined licensing pathway for biosimilars that has been proposed by the UK’s Medicines and Healthcare products Regulatory Agency offers the country the opportunity to play a world-leading role in biosimilars regulation, delegates to a Westminster Health Forum online conference on priorities for biosimilars in the National Health Service heard earlier today.

The MHRA set out plans for the pathway – which will typically not require comparative efficacy data and will consider approved biosimilars interchangeable with their reference products for all indications – last year, with a consultation ongoing

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