Business
Alvotech to Present Switching Study Data for AVT02, a Proposed Biosimilar to Humira®, at 2022 American College of Rheumatology Conference
Alvotech will present two posters and will be featured in an Ignite Talk related to its switching study for ATV02The switching study was conducted to
About this update from Alvotech
[{"type":"text","content":"Alvotech will present two posters and will be featured in an Ignite Talk related to its switching study for ATV02The switching study was conducted to investigate the pharmacokinetics, immunogenicity, efficacy and safety in patients undergoing repeated switches between Humira and AVT02Alvotech is the only known company that has both developed a high-concentration biosimilar candidate to Humira and completed a switching study to support interchangeability REYKJAVIK, Iceland, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it will present two posters and will be featured in an Ignite Talk related to its switching study for ATV02 at the American College of Rheumatology (ACR) Convergence Conference, being held in Philadelphia on November 10-14, 2022. The posters and Ignite Talk will provide detail on the data from Alvotech’s switching study for ATV02, a proposed high-concentration (100 mg/mL), citrate-free interchangeable biosimilar candidate for Humira® (adalimumab), conducted to investigate the pharmacokinetics (PK), immunogenicity, efficacy and safety in patients undergoing repeated switches between Humira and AVT02. Alvotech is the only known company that has both developed a high-concentration biosimilar candidate to Humira and completed a switching study to support potential regulatory approval as an interchangeable product. Alvotech’s Biologics License Application (BLA) for interchangeability between ATV02 and Humira® was accepted by the US Food and Drug Administration (FDA) in February 2022 and is currently under review by the FDA. Demonstration of interchangeability of biosimilars with originator products is a key component in supporting clinical practice by reducing healthcare costs and increasing patient access to biologic therapies. The biosimilarity of AVT02 to Humira has been previously assessed in both a PK study and a confirmatory efficacy and safety study, which supported the assessment of biosimilarity of AVT02. Alvotech’s poster titled “A Clinical Study Designed to Support a Demonstration of Interchangeability Between AVT02 and Humira®” will be presented in the Virtual Poster Hall on Saturday November 12, 2022, from 1:00 – 3:00 PM Eastern Time (ET). A second poster...