UK Could Become ‘World Leader’ On Biosimilar Regulation
Country’s Reduced-Data Pathway Could Be Followed By EU And US
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.
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Updated guidance on the UK’s new licensing pathway for biosimilars – which will typically not require comparative efficacy data – has been published by the MHRA after a stakeholder consultation. It has been warmly welcomed by the off-patent industry both locally and internationally.