On 28 September 2026, Teva announced that it has strengthened its position in the biosimilars market with the FDA approval of its internally developed Degevma™ (denosumab-adet), biosimilar to Amgen’s Xgeva®. Degevma™ is indicated for all approved reference indications and will be available as a 120mg/1.7mL solution for injection in a vial.
Teva’s biosimilar to Amgen’s Prolia® (denosumab) was approved in March 2026 as Ponlimsi™. Both Degevma™ and Ponlimsi™ are anticipated to be launched in the US “in the coming months”. The biosimilars were approved in the EU in November 2025.
The US has a highly competitive denosumab biosimilar market with numerous denosumab biosimilars already launched, including Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, launched January 2026), and Accord BioPharma’s Osvyrti® and Jubereq® (approved November 2025, launched July 2026).