Alvotech Provides U.S. Regulatory Update on AVT02, a High-Concentration Interchangeable Biosimilar Candidate to Humira (adalimumab)

Alvotech Provides U.S.

Regulatory Update on AVT02, a High-Concentration Interchangeable Biosimilar Candidate to Humira (adalimumab)

REYKJAVIK, Iceland, September 20, 2023

- Alvotech (NASDAQ: ALVO, or the "Company"), a global biotech company specializing in the development and manufacture of

biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has accepted Alvotech's

resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar candidate to Humira

(adalimumab). The FDA has also announced a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT02 BLA.

The BsUFA goal date provided

by the FDA is February 24, 2024. The FDA indicated that Alvotech's resubmission is considered to be a complete response to the agency's

June 28, 2023, action letter, given the additional Chemistry, Manufacturing and Controls information submitted by Alvotech with the BLA

to address manufacturing facility deficiencies identified earlier by the FDA.

"We remain committed to bringing AVT02 to patients in the U.S.,

where the need for a high-concentration, interchangeable biosimilar to Humira remains significant and unmet," said Robert Wessman,

Chairman and CEO of Alvotech. "No deficiencies in our BLA have been noted by the FDA other than those associated with our facility.

We now await further guidance from the FDA on timing of a reinspection, which we expect to occur in advance

An interchangeable biosimilar

may be substituted at the pharmacy without the intervention of the healthcare professional who prescribed the originator biologic, subject

to variations in state pharmacy laws and practices. No interchangeable high-concentration adalimumab biosimilar is currently available

About AVT02 (adalimumab)

AVT02 is a monoclonal antibody and that has been

approved as a biosimilar to Humira (adalimumab) in several countries globally, including the 27 member states of the

European Union, Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada, Australia, Egypt and Saudi Arabia. It is currently marketed

in multiple European countries and in Canada. Dossiers are also under review in multiple countries globally.

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), 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

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 regulatory approval 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 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; (18)

the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in

Ukraine and global geopolitical tension, and the ongoing and evolving COVID-19 pandemic on the Company's business, financial position,

strategy and anticipated milestones; and (19) 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

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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.

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