Biopharmaceutical company Shanghai Henlius Biotech, Inc. (2696.HK) and healthcare company Organon (NYSE: OGN) announced on Wednesday that the US FDA has accepted the Biologics License Application (BLA) for HLX14, a biosimilar candidate of PROLIA/XGEVA (denosumab).
Denosumab is widely used for treating osteoporosis in postmenopausal women at high fracture risk, among other indications.
In 2022, Henlius granted Organon exclusive commercialisation rights for HLX14 in key markets, including the US, EU and Canada, excluding China. The BLA is supported by comparative analytical and clinical studies demonstrating pharmacokinetic and efficacy similarity to PROLIA in high-risk postmenopausal women.
Henlius, with a focus on affordable biopharmaceuticals in oncology, autoimmune and ophthalmic diseases, has expanded globally with multiple approved products and a pipeline of over 50 molecules.
Henlius and Organon announce FDA acceptance of BLA for denosumab biosimilar, HLX14
Organon adds VTAMA cream to dermatology portfolio with acquisition of Dermavant
Redwire partners with Bristol Myers Squibb for space-based drug research
Accord Healthcare wins CHMP approval for Stelara biosimilar Imuldosa
Adicet Bio receives FDA clearance to expand ADI-001 trials to additional autoimmune diseases
Cantargia reports positive safety and biomarker results in CAN10 phase 1 trial
Lundbeck launches clinical trial for CD40L blocker Lu AG22515
Merck acquires CN201 from Curon Biopharmaceutical
Adicet Bio announces enrollment for Phase 1 trial to evaluate ADI-001 in autoimmune diseases