UK Could Become ‘World Leader’ On Biosimilar Regulation
Country’s Reduced-Data Pathway Could Be Followed By EU And US
Executive Summary
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.
You may also be interested in...
UK Lucentis Biosimilar Nod Offers Teva Potential First-Mover Advantage
Teva is gearing up to introduce the Ongavia ranibizumab biosimilar in the UK, following an approval by the local regulator ahead of its European counterpart. The development means the Israeli firm and partners Bioeq and Formycon could secure a global first launch of a rival to Lucentis, ahead of expected imminent launches by Samsung Bioepis of its Byooviz version in the US and Europe.
Health Canada Ponders UK Model On Easing Biosimilar Study Requirements
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.
UK Weathers Challenges Of COVID-19 And Brexit
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.