Healio14h
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 Executive1d
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, ...
Oncology Nurse Advisor2d
FDA Approves Denosumab Biosimilars Ospomyv and Xbryk
The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.
Center for Biosimilars1d
FDA Approves Another Pair of Denosumab Biosimilars, Conexxence and Bomyntra
The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for ...
clinicaladvisor.com8d
Denosumab Treatment Duration Predicts T-Score Achievement in Osteoporosis
Longer durations of denosumab treatment improved the probability of achieving target T-scores at the total hip and lumbar spine in postmenopausal women with osteoporosis. Denosumab treatment ...
JD Supra11h
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), ...
Chosunbiz9d
Osteoporosis drug Prolia faces intense competition as patents expire and generics launch
Osteoporosis drug Prolia faces intense competition as patents expire and generics launch Intense rivalry emerges in the ...
Drug Store News7d
FDA accepts BLA submission from Dr. Reddy's, Alvotech for proposed Prolia, Xgeva biosimilars
After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 ml ...
조선일보8d
Osteoporosis market faces competition as Prolia patent expires and generics emerge
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 ...
Alvotech and Dr. Reddy’s Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
“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 ...
rheumatologyadvisor11d
Denosumab Treatment Duration Predicts T-Score Achievement in Osteoporosis
Longer durations of denosumab treatment improved the probability of achieving target T-scores at the total hip and lumbar spine in postmenopausal women with osteoporosis. Denosumab treatment ...