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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