Nasdaq

Sandoz receives FDA approval for first and only denosumab biosimilars

Basel, March 5, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® ...

Biocon Biologics Receives U.S. Food and Drug Administration Approval for Bosaya™ and Aukelso™, Denosumab Biosimilars

Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (FDA) ...
Business Wire

FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYV™ (denosumab ...
KTLA

Celltrion USA announces U.S. launch of denosumab biosimilars, STOBOCLO® and OSENVELT® (denosumab-bmwo)

JERSEY CITY, N.J., July 7, 2025 /PRNewswire/ -- Celltrion USA today announced that STOBOCLO ® (denosumab-bmwo) and OSENVELT ® (denosumab-bmwo), biosimilars referencing PROLIA ® (denosumab) and XGEVA ® ...
WDTN

Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients[1]

WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are first and only FDA-approved interchangeable denosumab biosimilars available in US Improves access for patients living with osteoporosis and ...
Pharmabiz

US FDA approves Henlius & Organon’s Bildyos and Bilprevda, biosimilars to Prolia and Xgeva respectively

Shanghai Henlius Biotech, Inc., and Organon announced the US Food and Drug Administration (FDA) has approved Bildyos (denosumab-nxxp) injection 60 mg/mL and Bilprevda (denosumab-nxxp) injection 120 mg ...