Teva Pharmaceutical Industries Ltd. announced that the United States 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). This marks a significant step toward potentially broadening access to osteoporosis treatment.
Both the Biologics License Application (BLA) in the U.S., which seeks interchangeability, and the Marketing Authorization Application (MAA) in the European Union (EU), encompass all indications approved for the reference product, Prolia. These include conditions associated with a heightened risk of fracture, such as osteoporosis in postmenopausal women.
The FDA's decision and the EMA's opinion are anticipated in the second half of 2025. If approved, TVB-009P could offer a more affordable alternative to Prolia, which is used to treat osteoporosis and reduce the risk of fractures.
TVB-009P is the first of Teva’s internally developed biosimilars to be submitted to the U.S. FDA. The submissions are backed by a comprehensive analytical and clinical data package, featuring results from the randomized, double-blind TVB009-IMB-30085 Phase 3 trial. This trial investigated the safety and efficacy of TVB-009P versus Prolia in women with postmenopausal osteoporosis.
The submissions also incorporate data from the TVB009-BE-10157 pharmacokinetics and pharmacodynamics study in healthy volunteers, demonstrating pharmacokinetic similarity to the reference product.
Addressing Osteoporosis in Postmenopausal Women
Osteoporosis is a significant health concern, particularly among postmenopausal women. Hormonal changes during menopause elevate the risk of osteoporosis, affecting approximately 25% of older women in the U.S. and the EU. This condition increases the risk of bone fractures, with an estimated one in three women over 50 experiencing a fracture due to osteoporosis.
As of 2023, approximately 15 million women over the age of 50 in the United States had osteoporosis. In Europe, around 32 million people are affected, with an estimated 25.5 million being women. A significant number of these European women, approximately 14 million in 2019, remained untreated despite being eligible for therapy.
TVB-009P: A Biosimilar Candidate
TVB-009P is a monoclonal antibody and a biosimilar candidate to Prolia (denosumab). Denosumab targets RANKL (receptor activator of nuclear factor kappa-B ligand), a key protein involved in the regulation of bone metabolism and osteoclast formation. It is currently an investigational product and has not received regulatory approval in any country.
Teva's Perspective
"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."
