Dr. Reddy’s Laboratories (NYSE:RDY) and Alvotech (NASDAQ:ALVO) announced that the U.S. FDA has accepted a Biologic License Application submission for AVT03, which is a proposed biosimilar of Prolia ...

“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 ...

The FDA approved Stoboclo and Osenvelt, denosumab biosimilars that could offer more affordable treatment options for ...

Before you start treatment with Prolia, tell your doctor and pharmacist which prescription, over-the-counter, and other medications you take. By sharing this information with them, you may help ...

Samsung Bioepis received approval for two biosimilars of denosumab that are interchangeable with Prolia and Xgeva. Ospomyv provided similar BMD increases as Prolia for women with osteoporosis in a ...

On March 3, 2025, the FDA approved Celltrion’s denosumab biosimilars, STOBOCLO® (denosumab-bmwo; 60 mg/mL injection) and OSENVELT® (denosumab-bmwo; ...

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Ospomyv and Xbryk, biosimilars to Prolia and Xgeva, received FDA approval for osteoporosis and bone loss treatment. Clinical studies confirmed equivalent efficacy, safety, and pharmacokinetics ...

Findings from a phase 3 trial showed denosumab-dssb had comparable efficacy, safety, immunogenicity, PK and PD to Prolia in patients with postmenopausal osteoporosis. Ospomyv is approved to treat ...

Sandoz has claimed the first FDA approvals for biosimilars of Amgen’s blockbuster bone disease therapy denosumab, but has not said when it plans to launch them onto the US market. Amgen sells ...

The study included 2 treatment periods. During the first period, study participants (N=479) were randomly assigned 1:1 to receive denosumab-bmwo or the reference product. Patients who received the ...

STOBOCLO ® (denosumab-bmwo) and OSENVELT ® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA ® (denosumab) and XGEVA ® (denosumab) respecti ...