Alvotech Secures Settlement Agreement in Global Markets for its Biosimilar to Eylea® 2mg
Rhea-AI Summary
Alvotech (NASDAQ: ALVO) reached a global licensing and settlement agreement with Regeneron and Bayer resolving all remaining patent disputes for its aflibercept (Eylea) biosimilar. The deal grants worldwide manufacturing and supply rights to Alvotech’s partners and enables staged market entry beginning January 1, 2026.
Market dates include UK and Canada from Jan 1, 2026, Japan limited indications from May 1, 2026, broader Japan indications from Nov 1, 2026, and other countries (excluding U.S.) from May 1, 2026. Remaining terms are confidential.
Positive
- Worldwide manufacturing and supply rights secured
- Market access beginning January 1, 2026 in UK and Canada
- Regulatory approvals in EEA, UK, and Japan
- Named regional commercial partners in Europe and Japan
Negative
- U.S. launch remains pending regulatory approval and Q4 2026 license date
- Certain Japan indications delayed until November 1, 2026
- Key agreement terms remain confidential, creating investor uncertainty
Key Figures
Market Reality Check
Peers on Argus
ALVO’s pre-news move of -0.38% occurred alongside mostly negative peer action: SUPN -0.95%, BHC -1.22%, ANIP -1.33%, HCM -1.23%, while INDV gained 0.75%. No peers appeared in the momentum scanner and there were no same-day peer headlines, suggesting the Eylea biosimilar settlement is primarily company-specific rather than part of a coordinated sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 07 | Manager transaction correction | Neutral | +1.5% | Corrected regulatory disclosure on prior manager-related share transactions. |
| Jan 06 | Insider share purchases | Positive | -6.5% | Reported large share acquisitions by closely associated entities at SEK 44.06. |
| Jan 06 | CEO succession plan | Neutral | -6.5% | Planned transition from founder CEO to new CEO, highlighting pipeline scale. |
| Dec 31 | Term loan financing | Neutral | -2.5% | Secured USD 100M term loan at 12.50% interest to fund R&D and launches. |
| Dec 29 | Own-share notification | Neutral | -5.5% | Filed notice on changes in company’s own shares with Luxembourg CSSF. |
Recent news has often been followed by negative price reactions, including financing, leadership transition, and share-transaction disclosures, even when the underlying news was neutral or mixed.
In the last two months, Alvotech has focused on capital structure, leadership, and regulatory updates. A USD 100 million term loan facility maturing in December 2027 was secured to support R&D and launches, while a planned CEO succession was announced with 30 products in development and five marketed biosimilars highlighted. Multiple disclosures on share transactions and own-share changes drew generally negative reactions. Against this backdrop, the global settlement for the Eylea biosimilar extends an existing U.S. license arrangement into broader worldwide commercialization rights.
Market Pulse Summary
This announcement clarifies Alvotech’s global commercialization path for its Eylea biosimilar, resolving patent disputes with Regeneron and Bayer and setting firm launch dates in the UK, Canada, Japan and the European Economic Area. It builds on earlier disclosure of a U.S. license entry in Q4 2026 and existing approvals under local tradenames. In context with recent financing and leadership-transition news, investors may watch execution on launches, regulatory milestones, and how this asset contributes alongside the company’s broader biosimilar portfolio.
Key Terms
biosimilar medical
aflibercept medical
retinal diseases medical
Ministry of Health, Labour and Welfare (MHLW) regulatory
AI-generated analysis. Not financial advice.
REYKJAVIK, ICELAND (January 29, 2026) — Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has reached a licensing and settlement agreement with Regeneron and Bayer, resolving all remaining patent disputes worldwide related to Alvotech’s biosimilar to Eylea® 2mg (aflibercept 40 mg/mL solution), which is approved for marketing in the European Economic Area, United Kingdom and Japan. In combination with the previously announced agreement which granted a Q4 2026 license entry date for the U.S., pending regulatory approval, Alvotech now has worldwide rights to manufacture and supply its global commercial partners with the aflibercept biosimilar.
The settlement agreement allows Alvotech and its commercial partners to market and sell the biosimilar as of January 1, 2026 in the United Kingdom and Canada, as well as in Japan (excluding the diabetic macular edema indication) starting May 1, 2026 in the European Economic Area and all other countries in the world (other than the U.S.), and from November 1, 2026 in Japan with all approved indications. The remaining terms of the agreement remain confidential.
“Following our previously announced settlement with the originator for the U.S. market we are delighted to resolve all outstanding patent-related matters in the rest of the world. Our strong regional commercial partners are now very well positioned for a successful launch. Aflibercept remains the established and widely used treatment for various retinal diseases and we look forward to continuing to support our commercial partners, further advancing the long-term sustainability of global healthcare systems,” said Robert Wessman, Chairman and CEO of Alvotech.
Alvotech’s commercial partners for the Eylea biosimilar in Europe are Advanz Pharma (UK/EEA), STADA (DE) and Biogaran (FR), and for Japan Fuji Pharma Ltd. The biosimilar is approved by the European Commission for marketing in Europe under the tradenames Mynzepli® and Afiveg®. It is approved in the United Kingdom by the Medicines & Healthcare products Regulatory Agency (MHRA) under the tradename Mynzepli® and in Japan by the Japanese Ministry of Health, Labour and Welfare (MHLW) as Aflibercept BS.
CONTACTS
Media
Benedikt Stefansson
Sarah Macleod
alvotech.media@alvotech.com
Investors
Balaji Prasad (US)
Benedikt Stefansson (IS)
Patrik Ling (SE)
alvotech.ir@alvotech.com
About AVT06
AVT06 is a biosimilar to Eylea® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [1]. AVT06 has been approved under the brand names Mynzepli® (aflibercept) and Afiveg® (aflibercept) in the United Kingdom and European Economic Area and under the name AFLIBERCEPT BS for marketing in Japan.
Sources
[1] Mynzepli® product information, https://www.ema.europa.eu/en/documents/product-information/mynzepli-epar-product-information_en.pdf
Use of trademarks
Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc. and Bayer AG.
About Alvotech
Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disease, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
Forward-Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.
FAQ
What did Alvotech (ALVO) announce on January 29, 2026 about its Eylea biosimilar?
Which markets and effective dates did Alvotech (ALVO) confirm for its aflibercept biosimilar?
Does the settlement with Regeneron and Bayer let Alvotech (ALVO) sell the biosimilar in the U.S.?
Which commercial partners will distribute Alvotech’s (ALVO) Eylea biosimilar in Europe and Japan?
Is Alvotech’s aflibercept biosimilar approved in major jurisdictions now?
What indications and timing apply to Alvotech’s (ALVO) Japan launch for the aflibercept biosimilar?
