Teva Prolia (Denosumab) Biosimilar Candidate is Accepted for Review by FDA and EU EMA

Teva Pharmaceutical Industries Ltd. announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia (denosumab).

Both applications, a Biologics License Application (BLA) in the U.S., seeking interchangeability, and a Marketing Authorization Application (MAA) in the European Union (EU), 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 U.S. 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.

With over 120 years of experience in providing accessible and affordable medicines, Teva is one of the leaders in the biosimilar market with over 20 biosimilars in our portfolio and pipeline. “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, PhD, 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.”

Throughout the U.S. and Europe, over 165 million women are either in menopause or postmenopause. Hormonal changes during menopause place women at a higher risk for osteoporosis, which affects about 25% of older women in the U.S. and the EU. Osteoporosis increases the risk of bone fractures, and an estimated one in three women over the age of 50 will suffer a fracture due to this condition.