CHMP Adopts Positive Opinion on Alvotech’s Adalimumab Biosimilar

European Medicines Agency

European Medicines AgencyThe European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab).  Humira® is approved to treat certain inflammatory conditions.  Róbert Wessman, Founder and Chairman of Alvotech, announced, “We are delighted by the CHMP’s recommendation to approve our high-concentration biosimilar candidate for Humira.  Approval of AVT02 in the European Union would validate our global approach to biosimilar development.”  Mark Levick, CEO of Alvotech, added: “Alvotech is dedicated to making patients’ lives better by improving access to affordable biosimilar medicines as well as the sustainability of healthcare systems. Today’s news is another step in that direction.”