Recent Updates
Recently added Catalysts
ALVO Positive Sentiment Score: 80/100

Alvotech enters into commercialization agreement with Advanz Pharma for proposed biosimilar to Xolair (omalizumab) - Advanz Pharma will commercialize AVT23, a proposed biosimilar to Xolair (omalizumab) in the European Ec

Key Takeaway: Alvotech has signed an exclusive commercialization agreement with Advanz Pharma for AVT23, a proposed biosimilar to Xolair, covering multiple regions including the EU and Canada. Alvotech will focus on the development and manufacturing of AVT23, while Advanz Pharma will manage registration and commercialization efforts. The collaboration highlights a commitment to improving patient access to affordable biologics, with a potential market size exceeding $1 billion. However, it is important to note that AVT23 has not yet received regulatory approval, posing inherent risks.

Market Sentiment Analysis

POSITIVE FACTORS

  • Alvotech partners with Advanz Pharma to commercialize AVT23, expanding access to key treatments.
  • The agreement covers a significant market across Europe, the UK, Canada, Australia, and New Zealand.
  • The anticipated market for the reference product is over $1 billion, indicating a strong business opportunity.

CONCERNS & RISKS

  • AVT23 has not yet received regulatory approval, indicating risks in its market entry.
  • Biosimilarity has not been established, which may pose challenges for commercial acceptance.
  • There are various potential risks outlined that could affect the commercialization and launch of AVT23.

Full Press Release Details

Alvotech enters into commercialization agreement
with Advanz Pharma for proposed biosimilar to Xolair (omalizumab)
REYKJAVIK, ICELAND (February 6, 2023) Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture
of biosimilar medicines for patients worldwide, today announced that it has entered into an exclusive agreement with Advanz Pharma, for the commercialization of AVT23, a proposed biosimilar to
Xolair (omalizumab). The agreement covers the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand.
We look forward to working with Advanz Pharma on the commercialization of this important therapy in respiratory disease, said Anil Okay, Chief
Commercial Officer of Alvotech. This agreement highlights our joint commitment to provide better patient access to more affordable biologics around the world.
According to the agreement, Alvotech will be responsible for development and manufacture, while Advanz Pharma will handle registration and commercialization.
The estimated market size of the reference product for the region included under this agreement is over US$ 1 bn, according to market data from IQVIA.
In February 2022, Alvotech announced
an exclusive global licensing agreement with BiosanaPharma for the co-development of AVT23. Omalizumab is an antibody that targets free IgE and is used to treat patients with allergic asthma, chronic
spontaneous urticaria (CSU) and nasal polyps. AVT23 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
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
S mundargata 15-19 Phone +354 422 4500 alvotech.media@alvotech.com
102 Reykjav k, Iceland www.alvotech.com
(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.
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 success of its commercial partnerships, including its partnership with Advanz Pharma, potential milestone and royalty payments, the potential approval and commercial launch of its product candidates, the timing of regulatory
approvals and market launches, and the estimated size of the total addressable market of Alvotech s pipeline products, and the commercial success of AVT23, Alvotech s ability to improve global access to affordable biologics, and the effect
of biosimilars on inflationary pressures for healthcare systems. 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) changes in applicable laws or regulations; (3) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors;
(4) Alvotech s estimates of expenses and profitability; (5) Alvotech s ability to develop, manufacture and commercialize the products and product candidates in its pipeline, including AVT23; (6) actions of regulatory authorities,
which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (7) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the
satisfaction of the regulators; (8) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (9) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study
plans or sites; (10) the ability of Alvotech s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (11) Alvotech s ability to obtain and
maintain regulatory approval or authorizations of its products, including AVT23, including the timing or likelihood of expansion into additional markets or geographies; (12) the success of
S mundargata 15-19 Phone +354 422 4500 alvotech.media@alvotech.com
102 Reykjav k, Iceland www.alvotech.com
Alvotech s current and future collaborations, joint ventures, partnerships or licensing arrangements, including the partnership with Advanz Pharma; (13) Alvotech s ability, and
that of its commercial partners, to execute their commercialization strategy for approved products, including AVT23; (14) Alvotech s ability to manufacture sufficient commercial supply of its approved products, including AVT23; (15) the outcome
of ongoing and future litigation regarding Alvotech s products and product candidates; (16) 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 (17) 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
alvotech.ir[at]alvotech.com
S mundargata 15-19 Phone +354 422 4500 alvotech.media@alvotech.com
102 Reykjav k, Iceland www.alvotech.com

Frequently Asked Questions

What is Alvotech's new agreement about?

Alvotech has entered an exclusive agreement with Advanz Pharma for the commercialization of AVT23, a proposed biosimilar to Xolair.

What regions does the commercialization agreement cover?

The agreement covers the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand.

What role will Advanz Pharma play in the agreement?

Advanz Pharma will manage registration and commercialization, while Alvotech handles development and manufacturing.

What is AVT23 used to treat?

AVT23 is designed to treat allergic asthma, chronic spontaneous urticaria, and nasal polyps.

Has AVT23 received regulatory approval?

No, AVT23 is an investigational product and has not received regulatory approval in any country.

Last updated: Feb 6, 2023