With the US market cannibalized following several generic launches, Biogen, Inc. had earlier this year warned that generic competition to its Tecfidera (dimethyl fumarate) brand in the EU could appear “as early as the first half of 2022” as it continues efforts to overturn an unfavorable ruling that chopped the drug’s data- and marketing-protection periods.
Three EU Tecfidera Generics Recommended As Biogen Battles For Exclusivity
Mylan, Polpharma And Neuraxpharm Backed Amid Regulatory Tussle
Following a years-long back-and-forth to establish exclusivity protection for its Tecfidera multiple-sclerosis treatment in Europe, Biogen has ultimately seen the CHMP recommend three generic versions to receive pan-European marketing authorization.
More from Products
• By
While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.
• By
Spanish competition regulator the CNMC has announced an investigation into Sandoz and its Bexal subsidiary – as well as Alliance Healthcare España and Bluetab Solutions – over sharing sensitive commercial information relating to pharmacy orders for generics.
• By
Partnering opportunities, paused marketing, approvals, litigations, and many more. Formycon sets out the agenda for 2025, after seeing a bumpy start to the year.
• By
Four key areas for policy reform were identified by industry association Medicines for Europe at its biosimilars conference in early April, as sector chair Isabell Remus set out the importance of removing barriers to biosimilar competition.
More from Generics Bulletin
• By
Partnering opportunities, paused marketing, approvals, litigations, and many more. Formycon sets out the agenda for 2025, after seeing a bumpy start to the year.
• By
Four key areas for policy reform were identified by industry association Medicines for Europe at its biosimilars conference in early April, as sector chair Isabell Remus set out the importance of removing barriers to biosimilar competition.
• By
South Korea’s Celltrion has doubled down on its efforts in further building its pipeline, eyeing a target of 22 commercialized products by 2030 while also aiming to submit INDs for 13 novel compounds.