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Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®
The study, assessing pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® (golimumab) in healthy adult subjects, met its primary endpoint
About this update from Alvotech
[{"type":"text","content":"The study, assessing pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® (golimumab) in healthy adult subjects, met its primary endpoint Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). The study, which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult subjects, met its primary endpoints. “These results demonstrate the strength of our platform approach to biosimilars development and manufacture, combining a well-designed and executed clinical study with the design of a high-quality manufacturing process and strong analytical capabilities,” said Joseph McClellan, Chief Scientific Officer. “As we progress more biosimilar candidates through clinical development and approval, we continue to reaffirm our commitment to improving patient lives by expanding access to affordable biologics.” In May 2023, Alvotech announced the initiation of a clinical study to compare the efficacy, safety, and immunogenicity of AVT05 and Simponi® in adult patients with moderate to severe rheumatoid arthritis. In the last twelve months up to October 2023, combined worldwide revenues from sales of Simponi and Simponi Aria were nearly $2.2 billion [1]. Alvotech’s current portfolio of 11 products and product candidates includes one launched product, one approved biosimilar and four biosimilar candidates in clinical studies, including AVT05. About AVT05 AVT05 is a biosimilar candidate for Simponi® and Simponi Aria® (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha. Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [2]. 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. [1] Based on quarterly filings from Johnson & Johnson[2] https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI-pi.pdf About Alvotech Alvotech is a biotech company, ...