Applications for proposed first of a kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA

Novartis

25 July 2022 - Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple sclerosis in US and EU.

Sandoz announced today that the US FDA has accepted its biologics license application for a proposed first of a kind biosimilar natalizumab, developed by Polpharma Biologics.

Read Novartis press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , US , Biosimilar , Dossier