Pharmabiz16 天
US FDA approves Celltrion’s Stoboclo and Osenvelt biosimilars referencing Prolia and Xgeva
US FDA approves Celltrion’s Stoboclo and Osenvelt biosimilars referencing Prolia and Xgeva: Jersey City, New Jersey Wednesday, March 5, 2025, 18:00 Hrs [IST] Celltrion, a leadin ...
JD Supra14 天
FDA Approves Celltrion’s Denosumab Biosimilars
On March 3, 2025, the FDA approved Celltrion’s denosumab biosimilars, STOBOCLO® (denosumab-bmwo; 60 mg/mL injection) and OSENVELT® (denosumab-bmwo; ...
TipRanks on MSN3 天
Dr. Reddy’s, Alvotech announce FDA acceptance of BLA for AVT03
Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. Food and Drug Administration, FDA, has accepted a 351(k) Biologic ...
pharmaphorum2 天
Sandoz takes aim at Amgen's Prolia/Xgeva with biosimilar
Taken alongside Prolia/Xgeva, the brands account for well over 40% of Amgen's current revenues. Other companies working on biosimilar versions of denosumab include Samsung Bioepis, Celltrion, and ...