1. Alvotech and Teva settled licensing with Regeneron for AVT06 launch. 2. AVT06 is set for U.S. entry in Q4 2026 unless expedited. 3. Approval in Europe and Japan enhances market confidence for Alvotech. 4. Positive clinical study results affirm AVT06's efficacy compared to Eylea®. 5. Potential FDA approval is critical for U.S. market entry next year.
FAQ
Why Bullish?
The settlement and market approvals bolster Alvotech's prospects. Historical patterns show similar settlements improved competitor standings.
How important is it?
The announcement significantly impacts Alvotech's strategic positioning and revenue potential.
Why Long Term?
Market approvals suggest future revenue streams, developing a sustained positive outlook.
Alvotech and Teva Announce U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®
Reykjavik, Iceland; Tel Aviv, Israel; and Parsippany, N.J., Dec. 19, 2025 — Alvotech (NASDAQ: ALVO), a leading biotechnology company focused on biosimilars, alongside Teva Pharmaceuticals, has secured a significant license agreement with Regeneron Pharmaceuticals Inc. concerning the launch of AVT06, Alvotech’s biosimilar candidate to Eylea® (aflibercept), in the United States. This settlement establishes a license entry date for AVT06 in the fourth quarter of 2026, with potential for an earlier launch under specific conditions.
Strategic Import of the Settlement
Robert Wessman, Chairman and CEO of Alvotech, emphasized the importance of this development, stating, “Following recent marketing approvals in both Europe and Japan, we are delighted to secure a U.S. settlement date for our biosimilar candidate to Eylea®, an important biologic for the treatment of retinal diseases. This positions Alvotech and our commercial partner Teva very well for a successful launch in the U.S. market next year, pending FDA approval.”
Regulatory Approvals and Clinical Success
AVT06 has already received marketing approvals in the United Kingdom, Japan, and across the 30 countries of the European Economic Area (EEA), which encompasses all 27 EU member states plus Norway, Iceland, and Liechtenstein. Furthermore, in January 2024, Alvotech released positive top-line results from a confirmatory clinical study that established the efficacy, safety, and immunogenicity of AVT06 compared to Eylea®. This study met its primary endpoint, showcasing a high degree of similarity between the biosimilar candidate and the reference product Eylea®.
About AVT06 and Its Market Significance
AVT06 is designed as a biosimilar to Eylea® (aflibercept), a medication crucial in managing retinal diseases by binding to vascular endothelial growth factors (VEGF). This mechanism effectively inhibits the binding and activation of VEGF receptors, reducing neovascularization and vascular permeability. In the UK and EEA, AVT06 is marketed under the brand name Mynzepli®, while in Japan, it is known as AFLIBERCEPT BS.
Contacts for Further Information
For media inquiries, please contact:
- Alvotech Media: Benedikt Stefansson, Sarah Macleod - alvotech.media@alvotech.com
- Alvotech Investors: Balaji Prasad (US), Benedikt Stefansson (IS), Patrik Ling (SE) - alvotech.ir@alvotech.com
- Teva Media Inquiries: - TevaCommunicationsNorthAmerica@tevapharm.com
- Teva Investor Relations: - TevaIR@Tevapharm.com
Company Background
Alvotech is committed to becoming a global leader in the biosimilar market, focused solely on the development and manufacture of high-quality, cost-effective biosimilar medicines. The company aims to leverage its broad in-house capabilities to deliver innovative solutions to patients worldwide. Their pipeline currently includes eight biosimilar candidates targeting conditions such as autoimmune disorders, eye diseases, osteoporosis, respiratory diseases, and cancer.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), over 120 years old, is transforming itself into a leading innovative biopharmaceutical company, specializing in generics, biosimilars, and complex medicines. Teva’s mission centers on addressing patient needs through innovation in neuroscience and immunology.
Forward-Looking Statements
This communication may contain “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that could cause actual results to differ materially from expectations. These uncertainties may include factors affecting Alvotech’s ability to commercialize AVT06 and the associated regulatory processes.