US Tecfidera Sales Could Plunge By $2.8bn In 2021
Market Reacts To Mylan ‘At-Risk’ Launch
Generic competition to the one of the most lucrative small-molecule opportunities in the US arrived as Mylan pushed on with an “at-risk” launch to Biogen’s Tecfidera. Mylan’s fortunes and the ramifications of parallel litigation in a separate court were speculated by investors in the wake of the news.
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The sixth annual report of the FDA’s Office of Generic Drugs covered a year dominated by the novel coronavirus pandemic – although first-time generic approvals and record levels of communication also featured prominently.
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.