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.

EMA
The EMA's CHMP has recommended approval for Lupin's etanercept biosimilar • Source: Shutterstock

Mylan has been backed to receive a pan-European marketing authorization for Lupin’s Nepexto (etanercept) biosimilar by the European Medicines Agency’s Committee for Medicinal Products for Human Use, for all indications of Pfizer’s Enbrel reference product.

The European Commission usually acts on the CHMP’s opinion within 67 days, meaning that Lupin – which is looking to receive its first biosimilar approval in Europe – and Mylan expect a decision on the granting of a

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