U.S. FDA and EU EMA Accept Review of Teva's Prolia® (Denosumab) Biosimilar Candidate

Teva Pharmaceutical Industries Ltd. announced that the 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). These applications, a Biologics License Application (BLA) in the United States and a Marketing Authorization Application (MAA) in the European Union, cover all indications approved for Prolia, including osteoporosis in postmenopausal women. Decisions from both agencies are expected in the second half of 2025.

TVB-009P is Teva’s first internally developed biosimilar submitted to the U.S. FDA. The applications are backed by extensive analytical and clinical data, including results from the Phase 3 trial TVB009-IMB-30085, which compared the safety and efficacy of TVB-009P to Prolia in postmenopausal women with osteoporosis. Additionally, the applications include data from the TVB009-BE-10157 study, which demonstrated pharmacokinetic similarity between TVB-009P and the reference product.

Teva has over 120 years of experience in providing accessible medicines and is a leader in the biosimilar market, with over 20 biosimilars in its portfolio and pipeline. The company aims to broaden global access to biosimilars, leveraging its background in generics and biologics. Steffen Nock, PhD, Head of Biosimilars and Chief Scientific Officer at Teva, emphasized the company's dedication to offering more affordable treatment options and expanding its strategic partnerships and biosimilar portfolio.

Over 165 million women in the U.S. and Europe are either in menopause or postmenopause, with hormonal changes during this period increasing the risk of osteoporosis. This condition affects about 25% of older women in these regions, leading to a higher risk of bone fractures. An estimated one in three women over the age of 50 will experience a fracture due to osteoporosis.

Osteoporosis is characterized by low bone density, as bones lose the ability to reform and regrow with age. As of 2023, approximately 15 million women over 50 in the U.S. had osteoporosis. In Europe, about 32 million people are affected by osteoporosis, with 25.5 million being women. Despite eligibility, 14 million European women went untreated for osteoporosis in 2019.

TVB-009P (denosumab) is a monoclonal antibody and a biosimilar candidate to Prolia® (denosumab). Denosumab targets RANKL, a protein involved in bone metabolism and osteoclast formation. TVB-009P is an investigational product and has not yet received regulatory approval in any country.

Teva Pharmaceutical Industries Ltd. is a global pharmaceutical leader with a diverse portfolio, combining generics expertise with innovation. With a commitment to health spanning over 120 years, Teva continues to drive scientific innovation and deliver quality medicines through its global network.