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 ...

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 ...

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 ...

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 ...

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 ...

Osteoporosis is a common bone disease characterized by the progressive loss of bone mass and bone density. Osteoporosis ...

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 ...

OSPOMYV, referencing Prolia, has been approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in men with osteoporosis at ...