Pharmaceutical Technology on MSN
Teva receives FDA approval for Prolia biosimilar
The FDA approval for Ponlimsi is based on comprehensive evidence, including analytical and clinical data.
Teva’s biosimilar, PONLIMSI™, is now FDA-approved across all indications of the reference product, Prolia® (denosumab), to ...
The Food and Drug Administration has approved Teva's Prolia biosimilar and the agency is reviewing Teva's Xolair biosimilar application.
On March 30, 2026, the FDA approved Ponlimsi, a biosimilar to Prolia, and is reviewing a biosimilar candidate for Xolair.
BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced ...
Richter and Hikma have received the green light from the Food and Drug Administration for their biosimilar denosumab products, Enoby (denosumab-qbde) and Xtrenbo (denosumab-qbde), referencing Prolia ...
The Food and Drug Administration (FDA) has approved Osvyrti ® (denosumab-desu), a biosimilar to Prolia ® (denosumab), and Jubereq ® (denosumab-desu), a biosimilar to Xgeva ® (denosumab). Osvyrti is ...
The US Food and Drug Administration (FDA) has added a boxed warning to the label of the osteoporosis drug denosumab (Prolia) about increased risk for severe hypocalcemia in patients with advanced ...
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