Global pharma company Teva Pharmaceuticals has secured European Commission approval for two major denosumab biosimilars, boosting access to bone disease treatments.

 

The nod is for PONLIMSI, a biosimilar to Prolia, and DEGEVMA, a biosimilar to Xgeva, which follows a positive recommendation from the European Medicines Agency’s CHMP earlier this year.

 

The decision marks a significant expansion of Teva’s fast-growing biosimilars portfolio and strengthens the company’s push to broaden access to biologic medicines across Europe. Teva says it plans to roll out both products in key markets “in the coming months.”

 

The approvals also underscore the company’s Pivot to Growth strategy, aimed at accelerating its presence in high-value biologics and biosimilars.

 

“This is an important step forward in increasing patient access to biosimilar therapies for serious bone conditions,” said Steffen Nock, SVP Head of Biosimilars & Chief Science Officer.

 

Michal Nitka, SVP Head Generics Europe & Global Head OTC, added that Teva remains focused on expanding treatment options “especially in countries where access to biosimilars can still be improved.”

 

PONLIMSI (denosumab) is approved for treating osteoporosis in postmenopausal women and men at elevated fracture risk, bone loss linked to hormone ablation therapy in prostate cancer, and glucocorticoid-induced bone loss in adults.

 

It works by targeting RANKL, a key protein driving bone-resorbing osteoclast activity. Blocking RANKL reduces bone breakdown across cortical and trabecular bone. PONLIMSI will be supplied as a 60 mg/1 mL pre-filled syringe.

 

DEGEVMA (denosumab), on the other hand, is authorized for preventing skeletal complications in adults with advanced cancers involving bone, and for treating giant cell tumor of bone in adults and skeletally mature adolescents.

 

Like PONLIMSI, it inhibits RANKL to limit bone resorption. DEGEVMA will be available as a 120 mg/1.7 mL vial for injection.

 

With these approvals, Teva strengthens its position in Europe’s competitive biosimilars market—and opens the door to wider, more affordable access to denosumab-based therapies across the region.