Ponlimsi (denosumab-adet)

Biosimilar

Region: 🇺🇸 US
Active substance: denosumab-adet
Company: Teva Pharmaceuticals, Inc.
Status: Approved
FDA approval: Fri 27 Mar 2026
Designations: Biosimilar
Application: BLA761385
Official record: www.accessdata.fda.gov

Regulatory milestones

Fri 27 Mar 2026🇺🇸 FDA approval

FDA approves biosimilar Ponlimsi (denosumab-adet)

Teva Pharmaceuticals, Inc.; BLA761385; Biosimilar; injectable · source

Mon 17 Nov 2025🇪🇺 EU approval (EC decision)

Ponlimsi (denosumab) approved in the EU

Marketing authorisation to Teva GmbH; Biosimilar, Additional monitoring · source

Same substance in other markets

🇺🇸 Degevma Approved · Teva Pharmaceuticals, Inc.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.