Three EU Tecfidera Generics Recommended As Biogen Battles For Exclusivity
Mylan, Polpharma And Neuraxpharm Backed Amid Regulatory Tussle
Following a years-long back-and-forth to establish exclusivity protection for its Tecfidera multiple-sclerosis treatment in Europe, Biogen has ultimately seen the CHMP recommend three generic versions to receive pan-European marketing authorization.
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As Biogen provided an update on a potential sale of its biosimilars business – with the firm “engaged with multiple interested parties” – it also revealed Q2 sales and offered insights into off-patent competition to its Tysabri and Tecfidera brands.
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.
CNS specialist Neuraxpharm has purchased two of Sanofi’s product portfolios, substantially expanding the number of branded products it has to offer.