Novartis AG unit Sandoz Inc. won US approval of its biosimilar Erelzi, which is referenced on Amgen's tumor necrosis factor blocker Enbrel (etanercept). The product, however, currently is caught in a patent dispute, although a recent stipulation has provided some hope for a smoother path through the legal jungle than other biosimilars may face.
The expected FDA approval of Sandoz Inc.'s biosimilar version of Amgen Inc.'s tumor necrosis factor (TNF) blocker Enbrel (etanercept) came through on Aug. 30, bringing home the reality the latter firm could soon be facing competition for its $5bn in annual US sales once the new product is commercialized.
But the entrance of Erelzi (etanercept-szzs) into the US market could still be a ways away, given the ongoing litigation...
The world’s biggest pharmaceutical companies mostly saw growth in 2024 but 2025 promises to be more of a mixed bag with headwinds including losses of exclusivity, Medicare Part D redesign and challenges in the Chinese market.
The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
