Teva Pharmaceutical is accelerating its “Pivot to Growth” strategy, announcing three major milestones in its biosimilar portfolio. 

 

The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia, and Teva’s applications for a proposed biosimilar to Xolair (omalizumab) have been accepted by both the FDA and the European Medicines Agency (EMA).

 

“Our biosimilars R&D engine continues to demonstrate its depth and maturity. By combining deep internal expertise with strategic partnerships, we’re building a highly competitive portfolio," said Steffen Nock, PhD, Head of Biosimilars R&D and Chief Science Officer at Teva. “With a strong early-stage pipeline and a suite of advancing programs, we see significant potential to address patient needs and fuel Teva’s long-term growth.”

 

The FDA’s approval of PONLIMSI was based on comprehensive analytical and clinical data demonstrating a similar efficacy, safety, and immunogenicity profile to the reference product, Prolia. 

 

The drug is approved for all of Prolia’s indications, including treatment of osteoporosis in postmenopausal women and men at high risk for fracture, glucocorticoid-induced osteoporosis, and patients receiving cancer-related therapies that impact bone mass.

 

“The FDA approval of PONLIMSI is a significant milestone that showcases our robust clinical, analytical, operational and regulatory expertise,” said Yolanda Tibbe, Global Head of Biosimilars at Teva. 

 

“To receive US FDA approval of PONLIMSI and the filing acceptances of our proposed biosimilar candidate to Xolair in the US and Europe truly underscores the strength of our expanding global biosimilar portfolio and reaffirms our commitment to expand treatment options for patients.”