The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...

Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...

The Food and Drug Administration has approved Fresenius Kabi's Biologics License Application for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). These ...

After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 ml ...

Osenvelt is a receptor activator of NF-κb ligand inhibitor referencing Xgeva. The FDA approved the drug as a 120 mg/1.7 mL injection that is indicated to prevent skeletal-related events in ...

Please provide your email address to receive an email when new articles are posted on . Denosumab-bnht was approved as medication referencing Amgen’s Prolia and Xgeva. A settlement between Amgen ...

OSPOMYV™ (denosumab-dssb) injection, for subcutaneous use Ospomyv is a RANK ligand (RANKL) inhibitor indicated for treatment: SELECTED SAFETY INFORMATION CONTRAINDICATIONS These highlights do ...

Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. Food and Drug Administration, FDA, has accepted a 351(k) Biologic ...

Taken alongside Prolia/Xgeva, the brands account for well over 40% of Amgen's current revenues. Other companies working on biosimilar versions of denosumab include Samsung Bioepis, Celltrion, and ...