Posted by Michael Wonder on 03 Mar 2022
FDA accepts Alvotech’s BLA supporting interchangeability for ATV02, a high concentration, citrate-free biosimilar candidate for Humira
28 February 2022 - Alvotech is the only known company to have both developed a high-concentration biosimilar to Humira and conducted a switching study to support interchangeability.
Alvotech announced today that the U.S. FDA has accepted for review the company’s biologics licensing application for ATV02 (100 mg/mL) that includes new data supporting interchangeability between ATV02 and Humira.
