1. Generics Bulletin
  2. >>Products

Mylan And Lupin Get EU Etanercept Nod

European Commission's Final Decision On Biosimilar Approval Due By May

 
• By Dean Rudge

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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Biosimilars

More from Products

Amgen Biosimilars Continue Surge Ahead Of Imminent Denosumab Competition

 
• By Dean Rudge

Thanks to its efficient development pipeline, sales of Amgen’s biosimilars neared $750m for the first three months of the year, offering some comfort as the firm gears up for the loss of exclusivity for its denosumab franchise.

Adalvo And Gedeon Richter Join Forces On Semaglutide

 
• By Dave Wallace

Adalvo and Gedeon Richter have announced a global co-development deal for semaglutide for obesity. Adalvo CEO Anil Okay spoke to Generics Bulletin about the alliance as well as the broader competitive landscape for GLP-1s.

Tofidence And Tariffs - Organon Discusses Exposure Of Its Biosimilars Business

 
• By Dave Wallace

During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.