SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of January 2023
Commission File Number: 001-41421
(Translation of registrants name into English)
9, Rue de Bitbourg,
Grand Duchy of Luxembourg
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On January 24, 2023, Alvotech announced the approval of AVT02 (adalimumab) as Simlandi in Saudi Arabia. A copy of the press release is attached hereto as exhibit 99.1.
INCORPORATION BY REFERENCE
The information in this Report on Form 6-K, including Exhibit 99.1 hereto, is being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
|99.1||Press Release dated January 24, 2023.|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|Date: January 24, 2023||By:|
|Name: Tanya Zharov|
|Title: General Counsel|
Alvotech and Bioventure Announce
Approval of AVT02 (adalimumab) as Simlandi in Saudi Arabia
AVT02 as Simlandi is the first biosimilar approved under the strategic partnership between Alvotech and Bioventure
REYKJAVIK, ICELAND & DUBAI, UNITED ARAB EMIRATES (January 24, 2023) Alvotech (NASDAQ: ALVO) and Bioventure, a wholly owned subsidiary of GlobalOne Healthcare Holding LLC (GHH), the healthcare division of Yas Holding LLC, today announced that the Saudi Food & Drug Authority (SFDA) has approved the manufacturing and distribution of AVT02, a biosimilar for Humira® (adalimumab), which is commonly indicated for the treatment of rheumatoid arthritis and several other inflammatory diseases. The biosimilar will be marketed as Simlandi in Saudi Arabia.
A biosimilar is a biologic medicine that is highly similar to and has no clinically meaningful differences from an existing approved biologic medicine but can be more affordable than the reference product. In the last twelve months reported, ending on October 1, 2022, Humira (adalimumab) was the worlds highest grossing pharmaceutical product, other than COVID-19 vaccines, with global sales of US$21 billion, according to the manufacturer of the reference product .
The approval of Simlandi by the SFDA marks an important milestone for local patients and physicians, said Ashraf Radwan, Division CEO of GlobalOne Healthcare Holding. We are proud to partner with Alvotech, who share our mission to lower the cost burden on healthcare systems and improve patient quality of life. We look forward to bringing this essential treatment to patients in Saudi Arabia as well as other key markets in the Middle East and North Africa.
Robert Wessman, Founder, Chairman and CEO of Alvotech, added: Approval in Saudi Arabia is a significant step in Alvotechs journey to offer broader access worldwide to more affordable biologics. We believe that biosimilars are important in addressing inflationary pressures for healthcare systems in all markets, especially where the penetration of biologics has been depressed due to high cost and lack of access.
Bioventure is Alvotechs exclusive strategic partner for the commercialization of Simlandi in the Middle East and North Africa. Bioventure and Alvotech have previously entered into license agreements for multiple biosimilars.
Under the terms of the license agreement for AVT02 between Alvotech and Bioventure, Alvotech will handle development and manufacturing, while Bioventure will be responsible for the commercialization of the biosimilar. This is the first biosimilar approved under this strategic partnership.
 Source: Quarterly financial reports by AbbVie
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About AVT02 / Simlandi (adalimumab)
AVT02, marketed as Simlandi in Saudi Arabia, is a monoclonal antibody and approved biosimilar to Humira® (adalimumab), which inhibits tumor necrosis factor. The same biosimilar has been approved in the 27 countries of the European Union, Norway, Iceland, Liechtenstein, the UK and Switzerland as Hukyndra®; in Australia as Ciptunec / Ardalicip and in Canada as Simlandi. 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. Alvotechs 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. Alvotechs 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.
Established as the investment arm of GlobalOne Healthcare Holding LLC, Bioventure aims to support innovation, business development, and global reach of value-added healthcare solutions.
Bioventures three-strand approach includes licensing, investment, and increased market access. It helps pharmaceutical companies license biosimilars and new innovative products, as well as expand market presence and manufacturing capabilities. The company is the exclusive license holder for Alvotechs biosimilar portfolio and pipeline within the Middle East and Africa.
Bioventure partners with late-stage biotech as well as health/medtech startups, to help drive innovation and excellence within the region. It does so through licensing, registration, acquisition, and strategic investment. For more information, please visit: www.yasholding.ae/bioventure/
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About GlobalOne Healthcare
GlobalOne Healthcare Holding LLC operates as the Healthcare Division of Yas Holding LLC. With investments in leading bio-pharmaceuticals and innovative manufacturing solutions, GHH is delivering on its commitment to improve healthcare outcomes and patient quality of life. GHHs healthcare portfolio focuses on the provision of world-class healthcare services across a range of areas including customised clinical and non-clinical hospital management and healthcare consultancy services. Our companies specialise in biopharma, hospital management, medical supply chain, manufacturing, and occupational health.
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, Alvotechs 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 Bioventure, potential milestone and royalty payments, the potential approval and commercial launch of its product candidates, the timing of regulatory approvals and market launches, including in Saudi Arabia, and the estimated size of the total addressable market of Alvotechs pipeline products, and the commercial success of AVT02 in Saudi Arabia, the Middle East, North Africa and other countries, Alvotechs ability to improve global access to affordable biologics, 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 Alvotechs 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) Alvotechs estimates of expenses and profitability; (5) Alvotechs ability to develop, manufacture and commercialize the products and product candidates in its pipeline, including AVT02; (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 Alvotechs partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (11) Alvotechs ability to obtain and maintain regulatory approval or authorizations of its products, including AVT02, including the timing or likelihood of expansion into additional markets or geographies;
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(12) the success of Alvotechs current and future collaborations, joint ventures, partnerships or licensing arrangements, including the partnership with Bioventure; (13) Alvotechs ability, and that of its commercial partners, to execute their commercialization strategy for approved products, including AVT02; (14) Alvotechs ability to manufacture sufficient commercial supply of its approved products, including AVT02; (15) the outcome of ongoing and future litigation regarding Alvotechs products and product candidates; (16) the potential impact of the ongoing COVID-19 pandemic on the FDAs 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.
CONTACTS Alvotech Investor Relations and Global Communications
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