Teva Secures EU Approvals For Its Two Denosumab Biosimilars: PONLIMSI® To Prolia® And DEGEVMA® To Xgeva®

Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd., announced that the European Commission (EC) has granted marketing authorizations for its two denosumab biosimilar products, PONLIMSI (a biosimilar to Prolia®) and DEGEVMA (a biosimilar to Xgeva®). These approvals follow the positive recommendation issued earlier this year by the Committee for Medicinal Products for Human Use (CHMP).

The EC’s decision marks an important milestone in Teva’s expanding biosimilars portfolio and reinforces the company’s commitment to improving patient access to high-quality biologic therapies throughout Europe. Teva plans to introduce both PONLIMSI and DEGEVMA across major European markets in the coming months. The approvals also support Teva’s Pivot to Growth strategy, highlighting the company’s focus on broadening the availability of biosimilar medicines for patients who rely on them.

Steffen Nock, Senior Vice President, Head of Biosimilars and Chief Science Officer at Teva, noted that the authorizations represent a meaningful step toward expanding patient access to biosimilar treatments for serious bone-related conditions. He emphasized Teva’s ongoing commitment to improving care for patients through high-quality therapeutic options.

Michal Nitka, Senior Vice President, Head of Generics Europe and Global Head of OTC, added that the upcoming launches reflect Teva’s dedication to supporting healthcare systems across Europe. She explained that the company remains focused on increasing the availability of biosimilars, particularly in countries where access remains limited.