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 ...
The Pharma Letter1h
Sandoz launches biosimilar Pyzchiva in USA
Swiss generics and biosimilars major Sandoz has announced the launch of Pyzchiva (ustekinumab-ttwe) in the USA. From today, ...
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 RulesKey biosimilar value driver contributes to Sandoz global growth strategy ...
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 ...
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 ...
Yahoo Finance8d
Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (OBODENCE™, XBRYK™)
INCHEON, Korea, February 15, 2025--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled ...
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 ...
Business Wire8d
Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (OBODENCE™, XBRYK™)
INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled syringe ...
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 ...
Sandoz launches biosimilar Pyzchiva in U.S. for all approved Stelara indications
Monday said that Pyzchiva (ustekinumab-ttwe) is now commercially available to patients across the U.S. Developed by Samsung Bioepis Co., and commercialized by Sandoz, Pyzchiva has been approved by the ...