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

Rhea-AI Summary

Teva Pharmaceutical Industries announced that the U.S. FDA has accepted and the EU EMA has validated applications for TVB-009P, a biosimilar candidate to Prolia® (denosumab). The applications seek approval for all indications of 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 submissions are supported by comprehensive data, including results from a Phase 3 trial and a pharmacokinetics study. Teva, with over 120 years of experience, is a leader in the biosimilar market with 7 approved biosimilars and 16 in the pipeline.

The company aims to expand access to affordable treatment options, particularly for conditions like osteoporosis, which affects about 25% of older women in the U.S. and EU.

Positive

• Teva's biosimilar candidate TVB-009P has been accepted for review by both U.S. FDA and EU EMA
• Anticipated decision from both agencies expected in 2H 2025
• Teva has a robust biosimilar portfolio with 7 approved biosimilars and 16 in the pipeline
• Submissions supported by comprehensive data including Phase 3 trial results
• Potential to address a large market with over 165 million women in menopause or postmenopause in the U.S. and Europe

Negative

• None.

Insights

Medical Research Analyst

The FDA and EMA acceptance of Teva's biosimilar candidate for Prolia® (denosumab) is a significant development in the osteoporosis treatment landscape. This move potentially expands access to a important therapy for millions of postmenopausal women at risk of fractures. The Phase 3 trial results and comprehensive data package supporting the application suggest a high likelihood of approval.

Key points to consider:

• Teva's biosimilar could offer a more affordable alternative to Prolia, which had $3.2 billion in global sales in 2022.
• If approved with interchangeability status in the U.S., it could significantly impact market dynamics and patient access.
• The potential 2H 2025 approval timeline aligns with Prolia's patent expiration, positioning Teva well in the competitive biosimilar market.
• This submission marks Teva's entry into internally developed biosimilars, showcasing their R&D capabilities and strategic shift towards higher-value products.

For investors, this development signals Teva's growing presence in the lucrative biosimilars market, potentially driving future revenue growth and market share in a $800 billion global biologics market.

Financial Analyst

Teva's advancement in the biosimilars market, particularly with the Prolia biosimilar candidate, presents a significant opportunity for financial growth. Here's why this development is important for investors:

• Market Potential: The global osteoporosis market is projected to reach $14.7 billion by 2025, with Prolia as a leading treatment.
• Revenue Diversification: Success in biosimilars could help Teva reduce its reliance on generics, potentially improving profit margins.
• Competitive Advantage: Being among the first to market with a Prolia biosimilar could secure a substantial market share.
• Cost Efficiency: Teva's established manufacturing and distribution networks could provide a cost advantage over competitors.

However, investors should note that the biosimilar market is becoming increasingly competitive and pricing pressures may impact profitability. The 2025 expected approval also means no immediate revenue impact, requiring a longer-term investment outlook. Overall, this development strengthens Teva's pipeline and growth prospects in the high-value biologics sector.

• Prolia^® (denosumab) is indicated to treat certain conditions that lead to high risk for fracture, including osteoporosis in postmenopausal women
  
• TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of Teva’s robust biosimilar portfolio – 7 approved biosimilars and 16 in the pipeline – across critical therapeutic areas such as oncology, immunology and respiratory medicine
• Anticipated decision by both agencies is expected in 2H 2025
  

TEL AVIV, Israel, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today 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).¹

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.² 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.³

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.^4-6 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.^5-10 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.¹¹           

About Osteoporosis
Osteoporosis is a disease associated with low bone density as the bones lose the ability to reform and regrow themselves as we age.¹² As of 2023, about 15 million women over the age of 50 had osteoporosis in the United States.^5,9 In Europe, about 32 million people have osteoporosis, with 25.5 million estimated to be women.¹³ Of these European women, 14 million went untreated in 2019 despite being eligible.¹⁴

About TVB-009P (denosumab)
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. TVB-009P is an investigational product and has not received regulatory approval in any country.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop TVB-009P, a proposed biosimilar to Prolia^® (denosumab); risks that regulatory approvals and other requirements may delay the development and commercialization of our biosimilars; our ability to successfully launch and execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in this press release, in our Quarterly Report for the second quarter of 2024, and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the sections captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

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1. Prolia^® is a registered trademark of Amgen, Inc.
2. Teva Pharmaceuticals, Inc. (2024). A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04729621. Accessed October 3, 2024.
3. Data on File. Clinical Study report: Phase I Study TVB009-BE-10157. A Randomized, Double-Blind, Single-Dose, Parallel-Group Study to Investigate the Pharmacokinetic and Pharmacodynamic Similarity of TVB-009 Versus Denosumab (Prolia®) in Healthy Subjects Phase 1Study TVB009-BE-10157. Teva Pharmaceuticals.
4. Palacios, S., et al. (2010). Age of menopause and impact of climacteric symptoms by geographical region. Climacteric, 13(5), 419–428. https://doi.org/10.3109/13697137.2010.507886. Accessed October 3, 2024.
5. U.S. Census Bureau. (2022). Age and Sex. American Community Survey, ACS 1 -Year Estimates Subject Tables, Table S0101, 2022.
   https://data.census.gov/table/ACSST1Y2022.S0101?t=Age and Sex. Accessed October 3, 2024.
6. Eurostat. (2024). Population on 1 January by Age and Sex. https://ec.europa.eu/eurostat/databrowser/view/demo_pjan__custom_12638069/default/bar?lang=en. Accessed on October 3, 2024.
7. Riggs, B.L. (2000). The mechanisms of estrogen regulation of bone resorption. J Clin Invest, 106(10):1203-4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC381441/. Accessed October 3, 2024.
8. Salari, N., et al. (2021). Global prevalence of osteoporosis among the world older adults: a comprehensive systematic review and meta-analysis. J Orthop Surg Res, 16(1), 669. https://doi.org/10.1186/s13018-021-02821-8. Accessed October 3, 2024.
9. Walker, M.D., et al. (2023). Postmenopausal osteoporosis. NEJM, 389(21), 1979–1991. https://doi.org/10.1056/nejmcp2307353. Accessed October 3, 2024.
10. Kanis, J.A., et al. (2021). SCOPE 2021: A New Scorecard for Osteoporosis in Europe. Arch Osteoporos, 16(1):82.
11. Lorentzon M., et al. (2022). Osteoporosis and fractures in women: the burden of disease. Climacteric, (1):4-10. https://pubmed.ncbi.nlm.nih.gov/34319208/. Accessed October 3, 2024.
12. What are osteoporosis warning signs? (2024). Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/4443-osteoporosis. Accessed October 3, 2024.
13. Key Statistic for Europe: International Osteoporosis Foundation. (n.d.). https://www.osteoporosis.foundation/facts-statistics/key-statistic-for-europe. Accessed October 3, 2024.
14. Willers C., et al. (2022). SCOPE review panel of the IOF. Osteoporosis in Europe: a compendium of country-specific reports. Arch Osteoporos, 17(1):23. https://pubmed.ncbi.nlm.nih.gov/35079919/. Accessed October 3, 2024.

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FAQ

What is Teva's biosimilar candidate TVB-009P for Prolia® (denosumab)?

TVB-009P is Teva's biosimilar candidate for Prolia® (denosumab), designed to treat conditions with high risk for fracture, such as osteoporosis in postmenopausal women. It has been accepted for review by the U.S. FDA and EU EMA.

When is the expected decision date for Teva's TVB-009P biosimilar (TEVA)?

The anticipated decision from both the U.S. FDA and EU EMA for Teva's TVB-009P biosimilar is expected in the second half of 2025.

What clinical data supports Teva's TVB-009P biosimilar application (TEVA)?

Teva's TVB-009P biosimilar application is supported by a comprehensive data package, including results from a Phase 3 trial (TVB009-IMB-30085) and a pharmacokinetics study (TVB009-BE-10157) demonstrating similarity to the reference product.

How many biosimilars does Teva (TEVA) have in its portfolio and pipeline?

Teva has a robust biosimilar portfolio with 7 approved biosimilars and 16 in the pipeline across critical therapeutic areas such as oncology, immunology, and respiratory medicine.