Teva Receives European Commission Approval for PONLIMSI® and DEGEVMA®, Biosimilars to Prolia® and Xgeva®
Wednesday, November 26, 2025
Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd., has received marketing authorisation from the European Commission (EC) for its two denosumab biosimilars. PONLIMSI, a biosimilar to Prolia®, and DEGEVMA, a biosimilar to Xgeva®, were approved following a positive review by the Committee for Medicinal Products for Human Use earlier this year.
The approvals mark an important milestone in Teva’s expanding biosimilar portfolio and support the company’s aim to improve access to key biologic treatments across Europe. Teva plans to introduce both products in major European markets in the coming months.
These decisions also form part of Teva’s wider growth strategy and reinforce its focus on increasing the availability of biosimilar medicines for patients. The company noted that the approvals will help broaden treatment options for serious bone conditions and provide additional choices for healthcare systems across Europe, particularly in regions where biosimilar access remains limited.
Source: globenewswire.com
