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Alvotech Reports Update on Initial AVT02 Biologics License Application REYKJAVIK ICELAND (

Key Takeaway: Alvotech Reports Update on Initial AVT02 Biologics License Application REYKJAVIK ICELAND (September 5, 2022) Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that A

Full Press Release Details

Alvotech Reports Update on
Initial AVT02 Biologics License Application
REYKJAVIK ICELAND (September 5, 2022) Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture
of biosimilar medicines for patients worldwide, announced today that Alvotech received communication from the U.S. Food and Drug Administration (FDA) detailing its assessment of the March 2022 inspection of Alvotech s manufacturing facility in
Reykjavik, Iceland and Alvotech s subsequent written responses to the FDA.
The FDA s Complete Response Letter to the initial biosimilar
Biologics License Application (BLA) for AVT02 noted certain deficiencies related to the Reykjavik facility and stated that satisfactory resolution of the deficiencies is required before FDA may approve this BLA.
Alvotech looks forward to addressing the deficiencies outlined in the post-application action letter and continuing to work with the FDA to close out
the facility inspection. We aim to satisfactorily address the issues before the Biosimilar User Fee Act (BSUFA) goal date for the interchangeable biosimilar BLA in December, said Mark Levick, Chief Executive Officer of Alvotech. We are
committed to bringing AVT02 to patients worldwide and anticipate being launch ready by our expected launch date in the U.S. of July 1, 2023.
About AVT02 (adalimumab)
AVT02 is a monoclonal antibody
that is being evaluated for biosimilarity and interchangeability to Humira (adalimumab), which inhibits tumor necrosis factor (TNF). AVT02 has been approved in the EU, Norway, Iceland,
Lichtenstein, the UK, Switzerland, and Canada. AVT02 dossiers are under review in multiple countries, including in the United States.
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 contains eight 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), 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.
S mundargata 15-19 Phone +354 422 4500 alvotech.media@alvotech.com
Page 1 of 3 102 Reykjav k, Iceland www.alvotech.com
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 1955, 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, expected patient enrollment, regulatory review and
interactions, the satisfactory responses to the FDA s inspection findings and resolution of other deficiencies conveyed following the inspection of Alvotech s manufacturing site, the potential approval and commercial launch of its product
candidates, the timing of the announcement of clinical study results, regulatory approvals and market launches, and the estimated size of the total addressable market of Alvotech s pipeline products. 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 outcome of any legal proceedings that may be instituted against Alvotech or others following the business combination between Alvotech Holdings S.A., Oaktree Acquisition Corp. II and Alvotech; (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
S mundargata 15-19 Phone +354 422 4500 alvotech.media@alvotech.com
Page 2 of 3 102 Reykjav k, Iceland www.alvotech.com
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 potential impact
of the ongoing COVID-19 pandemic on the FDA s review timelines, including its ability to complete timely inspection of manufacturing sites; 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 Communication
alvotech.ir[at]alvotech.com
S mundargata 15-19 Phone +354 422 4500 alvotech.media@alvotech.com
Page 3 of 3 102 Reykjav k, Iceland www.alvotech.com
Last updated: Sep 5, 2022