- Alvotech to present two posters related to pharmacokinetics and confirmatory clinical studies for AVT04 (ustekinumab), a proposed biosimilar to Stelara®
- Marketing applications for AVT04 have been submitted in major markets including U.S. and Europe
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the presentation of two posters related to its clinical studies in support of biosimilarity and clinical comparability of Alvotech’s ATV04 (ustekinumab) and the reference product Stelara® at the 2023 American Academy of Dermatology (AAD) Annual Meeting, March 17-21 in New Orleans.
Earlier this year, Alvotech announced two regulatory updates for AVT04. In February 2023 Alvotech announced that a Marketing Authorization Application (MAA) filing for the biosimilar candidate was accepted by the European Medicines Agency’s (EMA) and in January 2023 that a Biologics License Application (BLA) was accepted for review by the U.S. Food and Drug Administration’s (FDA).
Alvotech’s poster, titled “Assessment of Bioequivalence Between Candidate Biosimilar AVT04 and Reference Ustekinumab,” details a pharmacokinetic (PK) study, AVT04-GL-101, conducted with healthy adult volunteers. The study involved a single dose, 3-arm, parallel design to compare pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5mL subcutaneous dose of AVT04 with US-licensed Stelara and EU-approved Stelara. In May 2022, Alvotech announced positive top-line results from the AVT04 PK study.
The second poster, titled “Assessment of Therapeutic Equivalence Between Candidate Biosimilar ATV04 and Reference Ustekinumab,” details a confirmatory clinical study, AVT04-GL-301. The randomized, double-blind, multicenter study was designed to demonstrate equivalent efficacy and to compare safety and immunogenicity between AVT04 and Stelara® in patients with moderate to severe chronic plaque-type psoriasis. In May 2022, Alvotech announced that the confirmatory study had met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and the reference product.
The posters will be available to view on the conference platform during the conference starting on March 17, 2023. Further information about the 2023 AAD Annual Meeting can be found here.
About AVT04 (ustekinumab)
AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses. AVT04 was developed using an Sp2/0 host cell line and is manufactured using a continuous perfusion process. AVT04 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/EEA, UK, Switzerland), 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.
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