EU approves AVT 02 as biosimilar to Humira.
The centralized marketing authorization in the European Union follows the recommendation of the Committee for Medicinal Products for Human Use’s (CHMP) for approval of AVT02 in September.
In September 2021 Alvotech announced top-line results from a randomized study in patients that demonstrate bioequivalence of repeated switches between administration of Humira (adalimumab) and Alvotech’s high-concentration biosimilar candidate, AVT 02 (adalimumab biosimilar) (100 mg/mL) to administration of Humira without switching. Further, no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and the reference product cohort.
After completing the lead-in period of 12 weeks under treatment with the reference product, eligible patients were randomized into either of the two arms of the switching module: the first group continued treatment with Humira, the second group continued treatment receiving alternating doses of AVT02 and Humira for an additional 16 weeks.
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