Following Mylan’s initial launch of a generic rival to Biogen’s $3.8bn Tecfidera brand, other generics companies are now following the firm into the US dimethyl fumarate market.
Multiple generic versions of Biogen’s $3.8bn Tecfidera (dimethyl fumarate) multiple sclerosis treatment have now been launched in the US.
Cipla, Dr Reddy’s and Camber Pharma are among those companies that have just confirmed launches of generics, following Mylan’s initial at-risk launch last month. This had come in the wake of a key legal victory that saw a West Virginia district court in June hold invalid Biogen’s US patent 8,399,514, which was due to protect Tecfidera through to February 2028
Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.
One of the biggest biologic loss-of-exclusivity opportunities of the year is almost upon us, as biosimilars developers across the world get ready to launch rivals to Amgen’s denosumab brands Prolia and Xgeva. Generics Bulletin offers a rundown of some of the major contenders and how they view the market.
An executive order from US president Donald Trump aimed at incentivizing domestic manufacturing of critical medicines has been welcomed by the US Association for Accessible Medicines.
The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.
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 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.
Reflecting on recent initiatives by NHS England and the MHRA, the newly renamed trade body Medicines UK has welcomed efforts in promoting the use of biosimilars in Britain.
