Denosumab is a monoclonal antibody that inhibits bone resorption and is widely used across oncology and osteoporosis-related ...
Original Medicare (Part A and Part B), Part D, and Medicare Advantage typically offer coverage for the osteoporosis drug Prolia. However, individuals must meet certain requirements for Part B coverage ...
Shanghai Henlius Biotech and Organon have received permission from the Food and Drug Administration for Bildyos (denosumab-nxxp) injection 60 mg/ml and Bilprevda (denosumab-nxxp) injection 120 mg/1.7 ...
Boncresa is supplied as a 60mg/mL single-dose prefilled syringe for SC injection and Oziltus is supplied as a 120mg/1.7mL single-dose vial for SC injection. Boncresa is approved to treat ...
Basel, March 5, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® ...
Findings showed denosumab-qbde demonstrated comparable quality, efficacy, safety, and immunogenicity to the reference product. Enoby is approved to treat postmenopausal women with osteoporosis at high ...
Generic drugmaker Sandoz (OTCQX:SDZNY) announced Tuesday that the FDA had approved two of its biosimilar products targeting Amgen’s (AMGN) blockbuster bone therapies, Prolia and Xgeva, collectively ...
Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the approval of AVT03, a proposed biosimilar of Amgen’s AMGN Prolia (denosumab) ...
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along ...
BENGALURU, India and BRIDGEWATER, N.J., Oct. 1, 2025 /PRNewswire/ -- Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON) ...