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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In a move that could hold major promise for the biosimilars industry, the European Medicines Agency has opened up a consultation on re-evaluating the need for comparative efficacy studies to support biosimilar applications.
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.