Having moved recently its projected launch date for its follow-on teriparatide proudct, US-based Pfenex has settled on the fourth quarter of next year for potential market entry, with a commercialisation partner secured and a legal strategy at hand.
Pfenex is maintaining a potential US launch date for the company’s PF708 follow-on alternative to Eli Lilly’s Forteo (teriparatide) “as early as” the fourth quarter of next year, after submitting its hybrid 505(b)(2) new drug application (NDA) with the US Food and Drug Administration (FDA).
The FDA’s review of the osteoporosis drug is expected to take around 10 months, Pfenex believes.
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.
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.
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.
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.
Collating data on the global manufacturing network of leading Indian drug makers, the markets serviced and production hubs for active pharmaceutical ingredients. Will ongoing geopolitical tensions and policy shifts have a bearing on some of these down the line?
