Teva's Biosimilars Expansion Advances With Key FDA Approval

Teva Pharmaceutical is accelerating its Teva’s biosimilars expansion with three major milestones that strengthen its “Pivot to Growth” strategy and reinforce its position in the global biosimilars market.

The company announced that the U.S. Food and Drug Administration has approved PONLIMSI (denosumab-adet), a biosimilar to Prolia. At the same time, regulatory applications for a proposed biosimilar to Xolair have been accepted by both the FDA and the European Medicines Agency.

“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.”

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The FDA approval of PONLIMSI was supported by extensive analytical and clinical data confirming comparable efficacy, safety, and immunogenicity to Prolia. The biosimilar is approved for all indications of the reference drug, including osteoporosis treatment in postmenopausal women and men at high fracture risk, glucocorticoid-induced osteoporosis, and bone loss linked to cancer therapies.

This Teva biosimilars expansion also highlights the company’s growing global regulatory success and pipeline strength in high-demand therapeutic areas.

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