Mylan And Lupin Get EU Etanercept Nod
European Commission's Final Decision On Biosimilar Approval Due By May
Mylan, in partnership with Indian firm Lupin, will be looking to rival Biogen and Sandoz by introducing an etanercept biosimilar in European markets following a positive opinion by the EMA’s CHMP on Mylan's application.
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Mylan and Lupin have revealed when they expect to launch their etanercept biosimilar, Nepexto, in Europe after receiving formal European Commission approval.
Despite having biosimilars of insulin glargine and etanercept that are expected to launch in the US and Europe respectively midway through this year, a biosimilar bevacizumab candidate filed in both regions, an in-development Botox rival still being considered and several other biosimilars already on the market around the world, Mylan insists that its biosimilars journey is just beginning.
Tentative FDA approval for Lupin’s arformoterol tartrate inhalation solution and a potential European nod for etanercept are seen aiding the company’s prospects in FY2021. Besides, success in a Phase III trial for secnidazole to treat trichomoniasis bodes well, though manufacturing clearances and continuity will also be closely watched.