FDA Clears Teva’s Ponlimsi, a Prolia Biosimilar, for All Indications

Overview

• Ponlimsi, which won FDA approval Monday, is cleared for all of Prolia’s approved uses.
• The decision drew on a totality of evidence showing similar efficacy, safety, and immunogenicity to the reference drug.
• The label flags severe hypocalcemia risk in advanced chronic kidney disease and lists contraindications in hypocalcemia and pregnancy.
• Clinicians are advised to evaluate chronic kidney disease–mineral bone disorder before treatment in high‑risk patients and to involve specialists when needed.
• Ponlimsi already holds European Commission authorization from November 2025 after a CHMP positive opinion, and Teva said regulators accepted filings for an omalizumab biosimilar.