FDA Approves Teva’s Denosumab Biosimilar to Xgeva

FDA has approved Teva’s DEGEVMA (denosumab-adet), a biosimilar to Amgen’s Xgeva, the company announced 28 September 2026. It is Teva’s second denosumab biosimilar approval this year — five months after PONLIMSI, its biosimilar to Amgen’s Prolia — and it lands in a Xgeva biosimilar field that is already crowded. What the approval does not settle, at least not in anything Teva or FDA has said publicly, is whether DEGEVMA can be substituted for Xgeva at the pharmacy counter without a prescriber's say-so.

What FDA approved

DEGEVMA is a biosimilar version of denosumab, the RANK ligand inhibitor Amgen sells as Xgeva for oncology indications and, at a different dose and schedule, as Prolia for osteoporosis. FDA's approval, cleared under the Section 351(k) biosimilar pathway, found no clinically meaningful differences between DEGEVMA and reference-product Xgeva in safety, purity and potency — the standard finding a biosimilar sponsor has to establish to win approval on the strength of comparative rather than independent clinical trials. The approved indications track Xgeva's label exactly: preventing skeletal-related events (pathologic fracture, radiation or surgery to bone, spinal cord compression) in adults with bone metastases from solid tumors; treating unresectable giant cell tumor of bone, or tumors where resection would likely cause severe morbidity, in adults and skeletally mature adolescents; and treating hypercalcemia of malignancy that has not responded to bisphosphonate therapy.

In the company's own words, from its 28 September announcement: “The approval of DEGEVMA is a powerful example of Teva's Pivot to Growth strategy in action because it represents an important step in expanding treatment options for patients and supporting healthcare systems with a high-quality biosimilar.” Teva says it expects to launch DEGEVMA — alongside PONLIMSI, its Prolia biosimilar — in the US “in the coming months,” without naming a date. DEGEVMA also holds a European Commission marketing authorization, granted in November 2025 following a positive CHMP opinion, so the US approval brings the product to a market where it is already cleared.

The open question: interchangeable, or not?

Xgeva biosimilars are not new. DEGEVMA joins a field that already includes Sandoz's Wyost, Celltrion's Osenvelt, Fresenius Kabi's Bomyntra, Biocon's Aukelso and Accord BioPharma's Jubereq, alongside the Prolia-indication counterparts sold under sister brand names. Several of those competitors carry FDA interchangeability designations, which let a pharmacist substitute the biosimilar for the reference product without contacting the prescriber, in states that allow it — a meaningful difference in how fast a biosimilar can take share once it launches. Nothing in Teva's announcement, or in the trade coverage of it, states that DEGEVMA has that designation. Regulatory News could not confirm the point either way from the public record, and is flagging it rather than assuming: RA and market-access teams should treat DEGEVMA as biosimilar-only, not interchangeable, until FDA's approval letter or its Purple Book listing says otherwise.

Why it matters beyond one more entrant

Denosumab is one of the most actively contested biosimilar categories in the US, and DEGEVMA's approval is a live data point on how FDA is applying the 351(k) “no clinically meaningful differences” standard to a complex biologic with two distinct reference indications. For RA teams building comparability packages for other biologics, that is a template worth watching. For market-access and formulary teams, it is one more name to slot into denosumab substitution and contracting decisions — and a reminder to check interchangeability status product by product rather than assume it from the word "biosimilar" alone.

Frequently asked questions

What did FDA approve?

DEGEVMA (denosumab-adet), Teva's biosimilar to Amgen's Xgeva, announced 28 September 2026, with indications matching Xgeva's full label: bone-metastasis skeletal-related-event prevention, giant cell tumor of bone, and hypercalcemia of malignancy.

Is DEGEVMA interchangeable with Xgeva?

Not stated publicly. Teva's announcement and the trade press covering it describe DEGEVMA only as a biosimilar; Regulatory News could not confirm an interchangeability designation either way and is flagging this as unresolved rather than assuming it.

Is this Teva's first denosumab biosimilar?

No. FDA approved Teva's PONLIMSI, a biosimilar to Amgen's Prolia, on 30 March 2026. DEGEVMA and PONLIMSI together give Teva biosimilars matched to both denosumab-branded products.

When does it launch?

Teva expects to launch DEGEVMA and PONLIMSI in the US "in the coming months," without a specific date or disclosed patent-settlement terms with Amgen.