FDA approves Teva's Degevma, a denosumab biosimilar-type product
Teva Pharmaceuticals, Inc. won approval for Degevma (denosumab-adet), a subcutaneous injectable, under BLA 761481.
The FDA approved Degevma, a product from Teva Pharmaceuticals, Inc., under application number BLA761481, with a submission status date of 2026-09-25. The approval covers a subcutaneous injectable formulation of denosumab-adet, with a strength of 120MG/1.7ML, equivalent to 70MG/ML.1
The submission was classified by the FDA as an original application, filed under submission class Type 5, New Formulation or New Manufacturer, carrying standard review priority.1 The record lists this as submission number 1, with status marked AP, indicating approval.
An approval letter tied to the application is on file with the FDA, dated 2026-09-29, documented in the agency's drug approval records. The filing is sponsored by Teva Pharmaceuticals, Inc.1
No further details on indication, dosing schedule, or clinical trial data supporting the approval are included in the FDA record reviewed for this report.
Fact check notes
- Imprecise
FDA approves Teva's Degevma, a denosumab biosimilar-type product
The approval facts (sponsor, drug name, BLA number) are correct, but the characterization of Degevma as a 'denosumab biosimilar-type product' is not stated in the source. The source only lists it as a Type 5 New Formulation/New Manufacturer submission with no mention of biosimilar status. - Checker's noteThe headline and implicit framing label Degevma as a 'biosimilar-type product,' but the FDA record provided does not state or classify it as a biosimilar.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Where the check questioned a sentence, its note is shown above. Not investment advice.