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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Blow For EU Tecfidera Rivals As Biogen Triumphs In Legal Battle
Developers of generic dimethyl fumarate have received a setback after a CJEU ruling in Biogen’s favor gave Tecfidera EU regulatory marketing protection until at least February 2024.
What’s Next? Five Things To Look Out For In December
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.
FDA Reviews Natalizumab For Sandoz And Polpharma
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.