Teva's Biosimilar to Prolia® (Denosumab) Accepted for Review by U.S. FDA and EU EMA
Wednesday, October 09, 2024
Teva Pharmaceutical Industries has 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).
Osteoporosis, a condition characterised by low bone density and an increased risk of fractures, affects around 25% of postmenopausal women in the U.S. and the EU. In total, over 165 million women are either in menopause or postmenopause across these regions, with one in three women over 50 estimated to suffer a fracture due to the condition.
TVB-009P, a monoclonal antibody, targets RANKL (receptor activator of nuclear factor kappa-B ligand), a protein that plays a key role in bone metabolism. It is currently an investigational product and has not yet received regulatory approval.
The submissions, which seek approval for all indications currently approved for Prolia, focus on conditions that increase the risk of fracture, such as osteoporosis in postmenopausal women. Decisions from both the FDA and EMA are expected in the second half of 2025.
The Biologics License Application (BLA) submitted to the FDA seeks an interchangeability designation, while the Marketing Authorization Application (MAA) was filed with the EMA.
These applications are supported by data from the Phase 3 TVB009-IMB-30085 trial, which evaluated the safety and efficacy of TVB-009P compared to Prolia in postmenopausal women with osteoporosis.
Additionally, data from a pharmacokinetic study in healthy volunteers confirmed the biosimilar’s similarity to the reference product.
Teva, a company with more than 120 years of experience in the pharmaceutical industry, has over 20 biosimilars in its portfolio and pipeline.
TVB-009P is the first internally developed biosimilar to be submitted to the FDA. Teva's strategy aims to provide more accessible and affordable treatment options through its growing biosimilars portfolio.
Source: globenewswire.com
