Biogen Will Assert New Tecfidera Patent Amid Hexal Germany Launch
Three Dimethyl Fumarate MAAs Were Approved By The EC In May
Biogen has conceded that generics to its Tecfidera treatment for relapsing remitting multiple sclerosis may launch “at risk” in the EU, after the US-based player was recently granted further patent protection until 2028.
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In a busy final month of the year, key legal action will be heard in both the US and Europe, while the Medicines Patent Pool will hear from applicants for a milestone voluntary licensing agreement covering Novartis’ nilotinib.
Sandoz and Polpharma have quickly followed news of a European natalizumab filing with confirmation that the proposed biosimilar version of Tysabri has also been accepted for review by the US Food and Drug Administration.
Polpharma Biologics has claimed the first biosimilar natalizumab filing in Europe, after the European Medicines Agency accepted the firm’s marketing authorization application for review.