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Alvotech Initiates Confirmatory Patient Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®
The clinical study will compare AVT05 and Simponi® in patients with moderate to severe rheumatoid arthritis Alvotech (NASDAQ: ALVO), a global biotech company
About this update from Alvotech
[{"type":"text","content":"The clinical study will compare AVT05 and Simponi® in patients with moderate to severe rheumatoid arthritis 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]. [1] Source: Johnson & Johnson quarterly reports. About AVT05AVT05 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...