Teva's Denosumab Biosimilar Accepted for Review by U.S. FDA and EU EMA

TEL AVIV, Israel, October 08, 2024 - Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) recently 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).

In the U.S., Teva has submitted a Biologics License Application (BLA) seeking interchangeability, while in the European Union (EU), a Marketing Authorization Application (MAA) has been presented. Both applications cover all indications approved for Prolia, including conditions like osteoporosis in postmenopausal women, which carries a high fracture risk. The FDA's decision and EMA's opinion are expected in the latter half of 2025.

TVB-009P is Teva's first internally developed biosimilar to be submitted to the U.S. FDA. The submissions are substantiated by a comprehensive analytical and clinical data package. This includes findings from the randomized, double-blind TVB009-IMB-30085 Phase 3 trial, which assessed the safety and efficacy of TVB-009P against Prolia in women with postmenopausal osteoporosis. Additionally, data from the TVB009-BE-10157 pharmacokinetics and pharmacodynamics study in healthy volunteers showed that TVB-009P has pharmacokinetic similarity to the reference product.

Teva, with over 120 years of experience in providing accessible medications, is a leader in the biosimilar market, boasting a portfolio and pipeline of over 20 biosimilars. Steffen Nock, PhD, Head of Biosimilars and Chief Scientific Officer at Teva, stated, “The filing acceptance and validation of TVB-009P underscore Teva’s commitment to expanding global access to biosimilars in both regions. We are leveraging our expertise in generics and our success with biologics, such as AJOVY®, to foster growth in the biosimilars market. Our objective is to broaden our strategic alliances and diversify our portfolio, offering more affordable treatment options for patients.”

In the U.S. and Europe, more than 165 million women are either in menopause or postmenopause. Hormonal changes during menopause increase the risk of osteoporosis, which affects about a quarter of older women in these regions. Osteoporosis significantly raises the risk of bone fractures, with one in three women over the age of 50 likely to experience a fracture due to this condition.

Osteoporosis is characterized by low bone density as bones lose their capacity to regenerate and strengthen with age. As of 2023, approximately 15 million women over the age of 50 in the U.S. were affected by osteoporosis. In Europe, around 32 million people suffer from osteoporosis, with 25.5 million being women. Despite eligibility for treatment, about 14 million European women went untreated in 2019.

TVB-009P (denosumab) is a monoclonal antibody and a biosimilar candidate to Prolia®. Denosumab targets the RANKL protein, essential in bone metabolism and osteoclast formation regulation. TVB-009P is still undergoing investigation and has not yet received regulatory approval in any country.

Teva Pharmaceutical Industries Ltd. is recognized globally as a pharmaceutical leader. With a strong heritage in generics, Teva is committed to innovation and development of modern medicines. The company's global network and workforce of approximately 37,000 employees across 58 markets are dedicated to improving health outcomes for millions of patients daily.