Clinical Efficacy And Safety Studies 'Redundant' For Most Biosimilars
‘Residual Uncertainty’ Surrounding Biosimilars Greatly Reduced Since WHO 2009 Guideline Publication
A team of researchers has concluded that in vivo animal studies and large safety and efficacy studies are rarely necessary to license biosimilars.
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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.
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.
The UK’s MHRA has laid out its plans for a biosimilar licensing pathway that will typically not require comparative efficacy data and will consider approved biosimilars interchangeable with their reference products for all indications. Local industry believes the guideline creates an opportunity for the UK to be the first launch market for biosimilars.