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Five More Circle Tecfidera With Ruling 'Unlikely To Be Reversed'

Delaware Decision Allows ANDA Sponsors To Launch

Executive Summary

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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Federal Circuit Cements Viatris Victory Over Biogen On Key US Tecfidera Patent

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 Rise Is Cold Comfort For Biogen As Tecfidera Competition Bites

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.

Floodgates Open For Tecfidera Rivals

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.

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