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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With Europe’s biosimilars industry bolstered by a recent statement from the EMA and HMA, as well as the prospect of a more streamlined regulatory pathway in future, Medicines for Europe’s biosimilars chair Isabell Remus and director of biosimilars policy and science Julie Maréchal-Jamil spoke to Generics Bulletin to discuss the path forward.
A team of researchers has concluded that in vivo animal studies and large safety and efficacy studies are rarely necessary to license biosimilars.
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.