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.
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Discussions are ongoing at Health Canada on the feasibility of adopting the UK model of easing clinical study requirements for biosimilars, said director general Celia Lourenco at a recent event. Meanwhile, the US FDA’s stance is unchanged for now.
Departing BGMA leader Warwick Smith highlights successes in the UK off-patent industry’s response to the COVID-19 pandemic but offers unambiguous criticism of Brexit in the concluding part of an exclusive interview with Generics Bulletin.
As Warwick Smith steps down after 25 years as leader of the British Generic Manufacturers Association, he talks about how far the country’s off-patent industry has come over the last quarter-century – including the acceptance of generics, the advent of biosimilars, and how freedom of pricing has helped to keep costs low while maintaining sustainable pricing – in the first part of an exclusive interview with Generics Bulletin.