With activity around denosumab biosimilars continuing to heat up, Fresenius Kabi has announced US FDA acceptance of its filing, while China’s Henlius says the EMA is reviewing its own biosimilar submission.
Fresenius Kabi has become the latest company to confirm a US Food and Drug Administration filing for a Prolia/Xgeva (denosumab) biosimilar, announcing that its version has now been accepted for review by the US agency.
The firm had reported midway through last year that its FKS518 candidate referencing Prolia (denosumab) successfully met its primary and...
Alvotech has acquired long-time partner Ivers-Lee to expand its in-house capacity for assembly and packaging ahead of key planned biosimilar launches in 2025, strengthening operational control and supporting global growth.
At Medicines for Europe’s annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap.
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?
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?
Sagent and Qilu will look to enhance access, reduce treatment costs, and strengthen supply chains after striking an alliance for a portfolio of the Chinese firm’s complex injectables.
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.
