Alvotech Beats Back AbbVie’s Trade Secrets Lawsuit
U.S. federal judge dismisses AbbVie's trade secret lawsuit against Alvotech, affirming its path to market a biosimilar to Humira. This ruling, delivered on October 6, 2021, supports Alvotech's goal to provide affordable medications. Alvotech has submitted a Biologics License Application for its candidate, AVT02, which aims for FDA interchangeability designation with Humira. Teva Pharmaceuticals is Alvotech's exclusive U.S. commercialization partner for AVT02, enhancing market opportunities in a space valued at US$20 billion globally.
- U.S. federal judge dismisses AbbVie's lawsuit, enabling Alvotech to advance its goals.
- Alvotech is on track to launch AVT02, a high-concentration biosimilar to Humira.
- Teva Pharmaceuticals is an exclusive partner for AVT02 commercialization in the U.S.
- None.
“Alvotech’s mission is to bring affordable medicines to market as soon as we can. Meritless accusations aimed at denying access to affordable medicines will not deter us from our mission and today serves as an affirmation of our efforts,” said Róbert Wessman, founder and chairman of Alvotech.
AbbVie’s lawsuit was another attempt to preserve its monopoly over Humira and prevent Alvotech’s proposed biosimilar from being available to patients in
Alvotech is the only known company that has both submitted a Biologics License Application (BLA) for a high-concentration biosimilar candidate to Humira, the most commonly utilized strength of the product on the market, and has successfully conducted a switching study in support of an FDA designation of interchangeability and correspondingly the potential for product substitution at the pharmacy level.
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
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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.
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 these slides and/or the press release of them 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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alvotech@berlinrosen.com
Source: Alvotech
FAQ
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