Biogen's US Tecfidera Sales Could Plunge By $2.8bn In 2021
Market Reacts To Mylan ‘At-Risk’ Launch
Mylan’s “at-risk” launch of a generic version of Biogen’s Tecfidera could cost the originator dear as generic competition to the one of the most lucrative small-molecule opportunities arrives in the US.
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Many clinicians doubt that aducanumab can really help slow the decline in Alzheimer’s patients – but US FDA could offer it the benefit of the doubt.
Facing an appeal on a favorable US district court decision, Mylan has opted to launch the first generic Tecfidera in the US “at risk,” after obtaining FDA approval and seeing Biogen’s bid for injunctive relief shot down earlier this month.
Amid several new and updated draft guidance documents and the potential approach of the first approval, interchangeability continues to be a buzzword in US biosimilars. AbbVie has projected that two Humira (adalimumab) biosimilars will hold the designation when they launch in 2023.