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Alvotech to Present Clinical Study Data for AVT04, a Proposed Biosimilar to Stelara®, at 2023 American Academy of Dermatology (AAD) Annual Meeting
Alvotech to present two posters related to pharmacokinetics and confirmatory clinical studies for AVT04 (ustekinumab), a proposed biosimilar to
About this update from Alvotech
[{"type":"text","content":"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 REYKJAVIK, Iceland, March 17, 2023 (GLOBE NEWSWIRE) -- 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 o...