Alvotech clinical trial results demonstrate curative equivalence between biosimilar candidate AVT06 and reference product Eylea® (aflibercept)

REYKJAVIK, Iceland, Jan. 03, 2024 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotechnology company focused on the progression and production of biosimilars for patients around the world, announced positive first-line effects from a confirmatory clinical study. study for AVT06, the biosimilar proposed through Alvotech to Eylea® (aflibercept).

“The progress of our product pipeline clearly illustrates the advantage of our integrated development and manufacturing platform, which allows Alvotech to pursue its diversified global biosimilar strategy,” said Robert Wessman, Chairman and CEO of Alvotech. “Completing this key clinical milestone for AVT06, also demonstrates how our integrated approach enables the rapid advancement of multiple high-quality biosimilar candidates simultaneously.”

Eylea is a biologic widely used for the treatment of eye disorders, adding diseases that can lead to vision loss or blindness, such as rainy AMD, macular edema, and diabetic retinopathy. In the twelve months to September 30, 2023, Eylea’s cumulative global sales amounted to approximately US$9. 4 billion [1].

About AVT06AVT06 is a recombinant fusion protein and biosimilar candidate for Eylea® (aflibercept), which binds to vascular endothelial expansion sites (VEGF), inhibiting VEGF receptor binding and activation, neovascularization, and vascular permeability. [2]. AVT06 is an investigational product and has obtained regulatory approval in any country. Biosimilarity has been established through regulatory governance and is affirmed.

[1] Regeneron Pharmaceutical Inc. , Quarterly Filings [2] Prescribing Information https://www. regeneron. com/downloads/eylea_fpi. pdf

Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.

About AlvotechAlvotech is a biotechnology company founded by Robert Wessman and focused solely on the development and production of biosimilar medicines for patients around the world. Alvotech seeks to become a global leader in biosimilars by offering high-quality, cost-effective products and services, made possible through fully incorporated technology and extensive in-house capabilities. Alvotech’s existing portfolio includes eight disclosed biosimilar applicants intended for the treatment of autoimmune diseases, eye disorders, osteoporosis, respiratory diseases and cancer. Alvotech has formed a network of strategic business partnerships to deliver global success and leverage local expertise in markets such as the United States, Europe, Japan, China and other Asian countries and major parts of South America, Africa and the Middle East. Alvotech’s commercial components are Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd. (USA), STADA Arzneimittel AG (EU), Fuji Pharma Co. , Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia). and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co. , Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co. , Ltd. (Thailand, Vietnam, Philippines and South Korea). Each business component covers a unique set of products and territories. Unless otherwise indicated, Alvotech disclaims all responsibility for the content of periodic documents, disclosures and other reports made through its components. For more information, visit www. alvotech. com. None of the data on Alvotech’s online page will be considered part of this press release.

CONTACTSInvestor Relations and Press Contact: Benedikt Stefansson, Senior Director of IR and Global [email protected]

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