The U.S. Food and Drug Administration approved Ponlimsi (denosumab-adet) as a biosimilar to Prolia for all indications of the reference product on March 30, according to Teva Pharmaceutical Industries Ltd.
The drug is approved to treat postmenopausal women with osteoporosis at high risk for fracture, increase bone mass in men with osteoporosis, treat glucocorticoid-induced osteoporosis, increase bone mass in men receiving androgen deprivation therapy for prostate cancer, and increase bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer.
The approval was based on a comprehensive data package, including results from a randomized, double-blinded phase 3 trial that evaluated the safety and efficacy of denosumab-adet versus Prolia in 332 women with postmenopausal osteoporosis.
Findings showed denosumab-adet was comparable to the reference product with regard to safety, efficacy, tolerability, and immunogenicity.
Ponlimsi is the tenth FDA-approved biosimilar to Prolia and comes with a boxed warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease.
Steffen Nock, head of biosimilars research and development at Teva, said the approval demonstrates the company’s “deep internal expertise” in building “a highly competitive portfolio.”
Separately, Teva announced the FDA and European Medicines Agency accepted applications for its proposed biosimilar candidate to Xolair (omalizumab) for review. The developments underscore growing industry efforts to introduce lower-cost alternatives to expensive biologic treatments, potentially expanding patient access to essential bone disease therapies.