Tony Hagen is senior managing editor for The Center for Biosimilars®.
Icelandic company Alvotech said clinical trials for its adalimumab candidate have demonstrated equivalence to reference product Humira.
Alvotech, of Reykjavik, Iceland, said its high-concentration adalimumab biosimilar (AVT02) has performed successfully in separate clinical trials for efficacy and pharmacokinetic (PK) similarity.
The company added that both studies demonstrated no clinically meaningful differences for safety, tolerability, and immunogenicity between AVT02 and the reference product (Humira).
Alvotech aims to eventually market AVT02 in the United States, Europe, and selected Southeast Asia markets.
A Partnership to Commercialize
In a March 2020 statement, Alvotech said it had partnered with DKSH, of Zurich, Switzerland, to commercialize AVT02. The biosimilar candidate has yet to be certified as a biosimilar or approved for marketing in any country.
AbbVie’s Humira is indicated for multiple autoimmune diseases, including rheumatoid arthritis, ankylosing spondlytis, plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn disease. Humira had worldwide sales of $18.4 billion in 2017.
AVT02 is being developed with a 100 mg/mL dose form that Alvotech believes will differentiate its product from “most biosimilar competitors, while matching the newest dosage forms of the reference product.”
The drug falls within the family of anti—tumor necrosis factor (TNF) agents. It contains a monoclonal antibody and blocks the activity of TNF, which normally helps the body control infection but leads to serious inflammation when produced in excess amounts.
The total market value for TNF-inhibitors in 2018 was over $40 billion and is expected to expand at the annual rate of 16.5% through 2026, Alvotech said.
An "Exciting Time" for Alvotech
“This is an exciting time for Alvotech as we advance the first biosimilar program another step closer to patients around the world. Our goal is to provide patients and healthcare providers with a cost-effective, accessible alternative to therapies which are currently available,” said Joseph E. McClellan, chief scientific officer at Alvotech.
In its statement, Alvotech explained that a phase 1 clinical study to compare the PK between AVT02 and Humira following a single 40 mg subcutaneous injection in health adult volunteers has met its primary objective. All primary PK end points were within equivalence margins, demonstrating PK similarity of AVT02 to the reference product.
The phase 3 comparative, confirmatory study for AVT02 also met its primary objective by demonstrating equivalent efficacy. The study is evaluating efficacy, safety, and immunogenicity of AVT02 compared with Humira in patients with moderate-to-severe chronic plaque psoriasis.
Alvotech announces positive top-line results for two comparative studies for AVT02, a proposed biosimilar to Humira (adalimumab). News release. Alvotech. May 12, 2020. Accessed May 14, 2020. www.alvotech.com/newsroom/alvotech-announces-positive-top-line-results-for-two-comparative-studies-for-avt02-a-proposed-biosimilar-to-humira-adalimumab