Samsung Bioepis Announces US Launch of PYZCHIVA® (ustekinumab-ttwe), Biosimilar to Stelara
Samsung Bioepis Co., Ltd. today announced that PYZCHIVA® (ustekinumab-ttwe), a biosimilar to Stelara (ustekinumab), is now available in the United States. PYZCHIVA has been approved for the treatment ...
Sandoz launches biosimilar Pyzchiva® (ustekinumab-ttwe) in the US, offering new treatment for around 12 million patients[1-4]
Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules Key biosimilar value driver contributes to Sandoz global growth strategy and moves company closer to becoming #1 in biosimilars ...
AFP1d
Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (OBODENCE™, XBRYK™)
Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled syringe) and XBRYK™ (120mg vial), denosumab biosimilars ...
The Pharma Letter6d
FDA and EMA green light Samsung Bioepis’ Prolia and Xgeva copies
South Korean biosimilars company Samsung Bioepis has announced that the US Food and Drug Administration (FDA) and European ...
Pharm Exec5d
FDA Approves Samsung Bioepis Biosimilars Ospomyv and Xbryk
Ospomyv, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Xbryk, a ...
JD Supra5d
Regulatory Updates on Samsung’s Denosumab Biosimilars
On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) ...
centerforbiosimilars6d
FDA, EMA Approve Second Pair of Denosumab Biosimilars
The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' ...
Healio6d
FDA approves two new biosimilars of denosumab
The FDA has approved two new biosimilars of denosumab-dssb to treat osteoporosis, increase bone mass, prevent ...
Business Wire8d
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 ...
Managed Healthcare Executive6d
FDA Approves Second Biosimilars for Prolia/Xgeva
Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis and multiple myeloma/bone metastases from solid tumors.