Full Press Release Details
Alvotech Initiates Confirmatory Patient Study for AVT05,
a Proposed Biosimilar for Simponi and Simponi Aria
REYKJAVIK, ICELAND (May 4, 2023) Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar
medicines for patients worldwide, announced today the initiation of Alvotech s confirmatory patient study for AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab). The objective of the clinical study is to compare the efficacy, safety, and immunogenicity of AVT05 and Simponi in adult
patients with moderate to severe rheumatoid arthritis.
It is a pleasure to be able to mark another clinical milestone in our biosimilars
development pipeline, said Joseph McClellan, Chief Scientific Officer. Alvotech s platform approach allows us to diversify and develop multiple product candidates in parallel. This is part of our strong commitment to improve patient
lives by expanding access to affordable biologics globally.
The AVT05 confirmatory patient study
(https://clinicaltrials.gov/ct2/show/NCT05842213) is a randomized, double-blind, 2-arm multicenter study comparing the efficacy, safety, and immunogenicity of subcutaneous AVT05 and EU-approved Simponi in patients with moderate to severe rheumatoid arthritis. The primary outcome measure will be to demonstrate comparative efficacy of AVT05 with Simponi at week 16 based on change from baseline on
a standardized Disease Activity Standard score (DAS28-CRP) which assesses the severity of rheumatoid arthritis using clinical and laboratory data. In January 2023 Alvotech announced the initiation of a
pharmacokinetic study for AVT05.
In the twelve months up to April 2023, combined net revenues worldwide from sales of Simponi and Simponi Aria were over
$2.1 billion, based on reported sales by the manufacturer of the reference product [1].
AVT05 is a biosimilar candidate for Simponi
and Simponi Aria (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha), a cytokine protein in the body. Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as
rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. AVT05 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 and select other territories), 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.
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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
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