Accord has received a nod from the EMA for its Stelara biosimilar, while Neuraxpharm has seen a buprenorphine hybrid film endorsed and Viatris has received a positive CHMP opinion for an eltrombopag generic.
The latest meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use has resulted in positive opinions for Accord Healthcare’s Stelara (ustekinumab) biosimilar as well as a buprenorphine hybrid film for Neuraxpharm and an eltrombopag generic for Viatris.
While CHMP positive opinions do not constitute formal approval, the European Commission typically acts within 67 days to convert them...
The announcement by Lupin and Zentiva of a development and commercialization deal on a certolizumab pegol biosimilar candidate has revealed a new potential challenger to Alvotech’s AVT10, previously thought to be the only Cimzia rival in development.
Pro-innovator voices argued that the number of patents asserted in the pharma industry is not too dissimilar to other fields. But should drugs be compared to golf balls?
Stada has appointed former Biogen biosimilars head Ian Henshaw as the new leader of its Specialty segment. Meanwhile, Craig Burton has left the AAM for Fresenius Kabi, Australia's GBMA is looking for a new chief executive, and Speranza, Outlook and EuroAPI have announced new appointments.
A third pair of Prolia and Xgeva rivals has now been launched in the US, with Celltrion throwing its hat into the ring after denosumab launches by Sandoz and Fresenius Kabi. But this is only the beginning for what is shaping up to be another highly competitive biosimilars market.
