The study explores whether Prolia/Xgeva (denosumab), a widely used therapy for osteoporosis and bone tumors, can regenerate ...

This month, Hanmi Pharmaceuticals and Samsung Bioepis entered into an agreement to develop and commercialize a denosumab biosimilar (SB16) referencing Amgen’s PROLIA ® in Korea. PROLIA ® is ...

On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...

Other companies working on biosimilar versions of denosumab include Samsung Bioepis, Celltrion, and AryoGen Pharmed. EU rules that all biosimilars are interchangeable ...

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.

Osvyrti ®– Bone / Osteoporosis (60mg Pre-Filled Syringe) Jubereq ®– Oncology (120mg Vial) Joe Dunford, Accord's Vice ...

Organon and Shanghai Henlius Biotech have announced that the European Medicines Agency (EMA) has validated a marketing ...

Number 5: Biosimilar natalizumab demonstrated comparable efficacy, safety, and immunogenicity to reference drug Tysabri in ...

It currently has more than 10 biosimilars in the pipeline, including versions of rituximab, ustekinumab and denosumab, with others acquired as part of its deal to buy a majority stake in mAbxience ...

Medscape Medical News, March 28, 2025 Alert 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 ...