Sandoz Canada Debuts Tecfidera Rival
Novartis Subsidiary Is Among First Approved Dimethyl Fumarate Generics
Sandoz has announced its launch of a generic rival to Tecfidera in Canada, with the firm among the first generics to be issued a notice of compliance by Health Canada.
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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.
Biosimilars sales rising by 8% to almost $800m in 2020 failed to offset the impact on Biogen of generic competition to its Tecfidera brand in the US.
Following Mylan’s initial launch of a generic rival to Biogen’s $3.8bn Tecfidera brand, other generics companies are now following the firm into the US dimethyl fumarate market.