Five More Circle Tecfidera With Ruling 'Unlikely To Be Reversed'
Delaware Decision Allows ANDA Sponsors To Launch
With a federal district court decision opening the door for a multitude of generic Tecfidera products, the market has reacted, suggesting as many as five ANDA products are primed for launch.
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As anticipated by the street, Viatris has prevailed over Biogen on the originator’s appeal of a district court ruling that invalidated a key US patent shielding its Tecfidera treatment for multiple sclerosis. However, the Federal Circuit was not aligned on its decision.
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.