Teva’s Prolia biosimilar candidate accepted for review by FDA, EU EMA

Teva shared that the Food and Drug Administration has accepted, and the European Medicines Agency has validated, applications for TVB-009P, a biosimilar candidate to Amgen’s Prolia (denosumab).

Both applications, a Biologics License Application in the United States, seeking interchangeability, and a Marketing Authorization Application in the European Union, include all indications approved for the reference product, Prolia, including conditions with a high risk for fracture, such as osteoporosis in postmenopausal women. The FDA’s anticipated decision and EMA’s expected opinion are anticipated in the second half of 2025.

TVB-009P, Teva’s proposed biosimilar to Prolia, is the first of Teva’s internally developed biosimilars to be submitted to the FDA. The submissions are supported by a comprehensive analytical and clinical data package including results from the randomized, double-blind TVB009-IMB-30085 Phase 3 trial investigating the safety and efficacy of TVB-009P versus Prolia in women with postmenopausal osteoporosis. The submissions also include data from the TVB009-BE-10157 pharmacokinetics and pharmacodynamics study in healthy volunteers, which demonstrated pharmacokinetic similarity to the reference product.

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“The filing acceptance and validation of TVB-009P, our proposed biosimilar to Prolia, underscores Teva’s commitment to broadening global access to biosimilars in both regions,” said Steffen Nock, head of biosimilars and chief scientific officer at Teva. “We are leveraging our strong background in generics and our successful track record with biologics, such as Ajovy, to drive growth in the biosimilars market. Our goal is to expand our strategic partnerships and enhance our portfolio, ultimately offering more affordable treatment options for patients.”

[Read more: Teva obtains FDA nod for generic Forteo]