On 30 March 2026, Teva Pharmaceutical Industries announced that the FDA has approved Ponlimsi™, biosimilar to Amgen’s Prolia® (denosumab). At the same time, Teva also announced that its regulatory applications for a biosimilar to Genentech/Novartis’ Xolair® (omalizumab) have been accepted for review by the FDA and the European Medicines Agency for all approved reference indications.
Ponlimsi® was approved in the EU in November 2025, together with Teva’s biosimilar to Amgen’s Xgeva® (denosumab), Degevma®. The US has a highly competitive denosumab biosimilar market with a number of 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), and Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, launched January 2026).
Teva’s omalizumab biosimilars are behind Celltrion’s Omlyclo® (omalizumab), which has already been approved in the EU (May 2024; high dose (300mg) form approved November 2025) and the US (March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status, and December 2025 in high dose). Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025. Aurobindo, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development.