Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...
The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...
The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for ...
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 ...
Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...
The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.
After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 ml ...
Osteoporosis drug Prolia faces intense competition as patents expire and generics launch Intense rivalry emerges in the ...
“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...
Last year, Prolia (generic name denosumab), a treatment for osteoporosis that generated an annual revenue of 9 trillion won worldwide, saw its patent sequentially expire in major countries starting ...