Blog Big Molecule Watch March 04, 2022

FDA Accepts Alvotech’s BLA Supporting Interchangeability for ATV02, a High Concentration, Citrate-Free Biosimilar Candidate for Humira®

Alvotech Holdings S.A. (“Alvotech”) announced on February 28th that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics Licensing Application (BLA) for ATV02 (100 mg/mL) that includes new data supporting interchangeability between ATV02 and Humira. According to Alvotech’s press release, the data are from a randomized study (AVT02-GL-302; NCT04453137) in patients that demonstrate bioequivalence of repeated switches between administration of Humira and AVT02 to administration of Humira without switching. Per previously reported studies, no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and the reference product cohort. According to the press release, “Alvotech is the only known company that has both developed a high-concentration biosimilar candidate to Humira and conducted a switching study[] to support potential approval as an interchangeable product.”

The release also notes that the U.S. FDA has communicated a goal date of December 2022 to reach a decision on the BLA.

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