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Top line results for AVT 02 shows no difference in switching with Humira.- Alvotech

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Published:12th Sep 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.

The purpose of the switching study is to support the potential approval of AVT02 by the FDA as an interchangeable product with Humira. Alvotech has both developed and submitted a filing for a high-concentration biosimilar candidate to Humira, as well as conducted a switching study to support potential approval as an interchangeable product. Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. is the exclusive strategic partner for the commercialization of AVT02 in the United States.

Condition: RA/AnkSpon/Crohns/UC/PsA/Ps

Type: drug

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