Alvotech signs U.S. agreement to expand access for newly approved high-concentration interchangeable biosimilar to Humira® (adalimumab)

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Alvotech, in partnership with Teva Pharmaceuticals, has signed an agreement with a strategic partner to introduce the newly FDA approved high-concentration interchangeable biosimilar to Humira to the U.S. market. This agreement aims to improve patient access to vital biologics in the U.S. and globally. The long-term partnership reflects Alvotech's commitment to providing more affordable healthcare options. Teva Pharmaceuticals will continue to commercialize the biosimilar under the SIMLANDI brand in the U.S.

Pharmaceutical Market Analyst

The collaboration between Alvotech and the undisclosed strategic partner has the potential to disrupt the biologics market by introducing a competitively priced biosimilar alternative. Increased access to affordable biosimilars like adalimumab-ryvk can drive down healthcare costs, potentially leading to lower insurance premiums and out-of-pocket expenses for patients. There may be a market share shift as prescribers and healthcare systems opt for cost-effective therapies. However, the scale of impact on Alvotech's financials will depend on market adoption rates, the competitive landscape and the pricing strategy adopted.

Biotech Industry Legal Analyst

The aspect of interchangeability is a significant boon for Alvotech's biosimilar. It suggests that the FDA approves the substitution of adalimumab-ryvk for Humira without prescriber intervention, which is not always the case with biosimilars. This could greatly enhance market penetration. However, legal challenges or pushback from the originator company, AbbVie, could still arise, as the biologics market is known for its patent litigation. Investors should monitor the legal environment surrounding biosimilar introductions closely, as any litigation could impact timelines and costs associated with the rollout of adalimumab-ryvk.

• Alvotech, in agreement with Teva Pharmaceuticals, has signed an agreement with a strategic partner to bring to the U.S. market the newly FDA approved high-concentration interchangeable biosimilar to Humira^®
  
  
• The agreement broadens patient access and further commitment to availability of vital biologics in the U.S. and globally
  

REYKJAVIK, Iceland, April 19, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today a long-term agreement with a strategic partner to further enhance access to Adalimumab-ryvk in the U.S. market, the newly U.S. Food and Drug Administration (FDA) approved high-concentration interchangeable biosimilar to Humira.

“This new partnership agreement supports our financial guidance and reflects Alvotech’s strong commitment to increasing patient access to more affordable healthcare,” said Robert Wessman, Chairman and CEO of Alvotech.

The current multi-product commercialization partnership between Teva Pharmaceuticals and Alvotech remains unchanged and Teva will continue to commercialize adalimumab-ryvk under the SIMLANDI^® brand in the U.S.

Use of Trademarks
Humira^® is a registered trademark of AbbVie Biotechnology Ltd.

About Alvotech
Alvotech is a biotech 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 disorders, 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. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), 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 commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. 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 generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential”, “aim” or “continue”, or the negatives of these terms or variations of them or similar terminology. 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: (1) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech’s estimates of expenses and profitability; (6) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company’s business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties 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. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. 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. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication.

ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, Senior Director
alvotech.ir@alvotech.com

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FAQ

What agreement did Alvotech sign regarding the high-concentration interchangeable biosimilar to Humira?

Alvotech signed an agreement with a strategic partner to bring the newly FDA approved biosimilar to the U.S. market.

When was the high-concentration interchangeable biosimilar to Humira approved by the FDA?

The high-concentration interchangeable biosimilar to Humira was newly approved by the FDA.

Which company will continue to commercialize the biosimilar in the U.S. under the SIMLANDI brand?

Teva Pharmaceuticals will continue to commercialize the biosimilar in the U.S. under the SIMLANDI brand.

What is the ticker symbol for Alvotech?

The ticker symbol for Alvotech is ALVO.