REYKJAVIK, Iceland--(BUSINESS WIRE)--Alvotech today welcomed the positive opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab). The CHMP’s positive opinion will now be referred to the European Commission (EC) for the decision to grant a marketing authorization for AVT02. If approved, a centralized marketing authorization for AVT02, would extend to all EU Member States, as well as countries in the European Economic Area (EEA), Iceland, Liechtenstein and Norway.

Adalimumab inhibits tumor necrosis factor, which is a protein in the body that causes inflammation. Adalimumab is used to treat certain inflammatory conditions. Humira recorded global sales of about US$20 billion in 2020, making it the largest-selling biologic medicine in the world.

“We are delighted by the CHMP’s recommendation to approve our high-concentration biosimilar candidate for Humira,” said Róbert Wessman, Founder and Chairman of Alvotech. “Approval of AVT02 in the European Union would validate our global approach to biosimilar development.”

Mark Levick, CEO of Alvotech, added: “Alvotech is dedicated to making patients’ lives better by improving access to affordable biosimilar medicines as well as the sustainability of healthcare systems. Today’s news is another step in that direction.”

About Alvotech:

Alvotech is a multinational biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets. We are specialists in biotechnology, seeking to be a global leader in the biosimilar space by delivering high quality, cost-competitive products and services to our partners and to patients worldwide. Our fully integrated approach, with high-quality in-house competencies throughout the value chain, enables the accelerated development of biosimilar products. Alvotech’s shareholder base includes, among others, Aztiq Pharma, led by founder and Chairman Mr. Róbert Wessman, Fuji Pharma from Japan, YAS Holdings form Abu Dhabi, Shinhan from Korea, Baxter Healthcare SA from the US, ATHOS (Strüngmann Family Office) from Germany and CVC Capital Partners and Temasek from Singapore through their participation in Alvogen.

Alvotech’s initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions to improve quality of life for patients around the world. For more information, please visit our website, www.alvotech.com or follow us on LinkedIn, Twitter and Facebook.

About AVT02:

AVT02 is a monoclonal antibody and a proposed biosimilar to Humira (adalimumab). AVT02 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities and is not yet claimed.

Forward Looking Statement:

Except for historical information contained herein, the matters set forth in this press release are forward looking statements that are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are not based on historical facts but rather on our expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities. Statements in this press release about our future plans and intentions, results, level of activities, performance, goals or achievements or other future events constitute forward looking statements. There are a number of factors which could cause actual results or developments to differ materially from those expressed or implied by such forward-looking statements. Any of the assumptions underlying forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in forward-looking statements may not actually be achieved. Nothing contained in this press release should be construed as a profit forecast or profit estimate. Wherever possible, words such as “anticipate”, “believe”, “expect”, “may”, “could”, “will”, “potential”, “intend”, “estimate”, “should”, “plan”, “predict”, or the negative or other variations of statements reflect management’s current beliefs and assumptions and are based on the information currently available to our management. 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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