Medscape6d
FDA Approves Fourth Denosumab Biosimilar
Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...
Healio6d
FDA grants approval to two more denosumab biosimilars
The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, ...
Managed Healthcare Executive6d
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...
Targeted Oncology1d
FDA Oncology Actions: March 2025 Approvals and Designations
On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...
JD Supra5d
FDA Approves Fresenius’s Denosumab Biosimilars
On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), ...
Le Lézard6d
Fresenius Receives FDA Approval for their Denosumab Biosimilars and Secures Global Settlement Agreement
Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi, has ...
Accord Healthcare Receives Positive CHMP Opinion for Denosumab, Osvyrti®, and Jubereq®
Osvyrti ®– Bone / Osteoporosis (60mg Pre-Filled Syringe) Jubereq ®– Oncology (120mg Vial) Joe Dunford, Accord's Vice ...
Zacks.com on MSN3d
RDY & Bio-Thera Ink Deal for JNJ's Stelara/Simponi Biosimilar
Dr. Reddy's inks collaboration deal with Bio-Thera to develop and commercialize proposed biosimilar candidates of J&J's Stelara and Simponi in Southeast Asia.
pharmaphorum3d
Sandoz takes aim at Amgen's Prolia/Xgeva with biosimilar
Other companies working on biosimilar versions of denosumab include Samsung Bioepis, Celltrion, and AryoGen Pharmed. EU rules that all biosimilars are interchangeable ...