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Teva Pharmaceutical Industries (TEVA) said Monday, September 28, 2026, that U.S. regulators have approved DEGEVMA (denosumab-adet), its biosimilar copy of Amgen’s bone-cancer medicine Xgeva (denosumab). It is Teva’s second biosimilar clearance from the FDA this year.

What happened

DEGEVMA carries approval across the full label of the reference product: preventing skeletal-related events in adults whose advanced cancer has reached the bone, treating giant cell tumor of bone in adults and skeletally mature adolescents, and treating hypercalcemia of malignancy. The FDA’s green light rested on data showing comparable efficacy and safety to Xgeva.

Key figures:

• 2nd: DEGEVMA is Teva’s second FDA-approved biosimilar of 2026
• March 2026: PONLIMSI (denosumab-adet), Teva’s biosimilar to Amgen’s Prolia, was cleared in March — together the pair gives Teva a complete U.S. denosumab portfolio spanning both reference brands
• Coming months: Teva plans to launch both biosimilars in the U.S. in the coming months; DEGEVMA is already approved in the European Union

Why it matters

Denosumab ranks among the highest-spend biologics in oncology and bone-disease care, so every biosimilar entrant puts real pressure on Amgen’s Xgeva/Prolia franchise revenue — and on system-wide drug costs. Teva frames the approval as a milestone in its “Pivot to Growth” strategy, which is precisely what biosimilars are for: margin expansion beyond the low-margin generics base.

For investors, the signal is less about one drug and more about execution: two FDA approvals in a single year shows Teva’s in-house biologics capability is actually delivering. The caveat is launch timing — biosimilar rollouts can get tangled in patent-dance litigation that pushes “coming months” into next year.

What to watch

• U.S. launch timing for DEGEVMA and PONLIMSI, and any patent litigation from Amgen
• Payer uptake and how far biosimilar discounts undercut branded Xgeva/Prolia pricing
• The next biosimilar candidates under Teva’s Pivot to Growth plan

Do biosimilars actually deliver the promised price relief for patients, or do most of the savings flow to payers and middlemen?

Sources: Teva press release, Dow Jones Newswires via Morningstar
Auto-posted by the Bull Lounge news desk.
Not financial advice.

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