The rheumatology and gastroenterology biosimilar candidate would enter the lucrative market established by Humira.
Alvotech of Reykjavik, Iceland, said its adalimumab biosimilar candidate (AVT02) has been accepted for regulatory review by the FDA and the European Medicines Agency (EMA).
The drug references AbbVie’s top-selling Humira for the treatment of arthritis, psoriasis, ankylosing spondylitis, Crohn disease, and ulcerative colitis. The product candidate submitted for review is a high-concentration, 100-mg/mL dose form that matches the newest formulation of Humira, Alvotech said.
An FDA decision on the biologics license application is expected in September 2021, while the EMA decision whether to issue marketing authorization for AVT02 is anticipated in the fourth quarter of 2021, Alvotech said.
“The filings were based on the results of a comprehensive development program and data package comprising of a totality of evidence demonstrating a high degree of similarity of AVT02 compared to its reference product,” said Joseph E. McClellan, PhD, MBA, company chief scientific officer.
The pharmacokinetic (PK) study AVT02-GL-101 successfully established PK similarity between AVT02 and the reference product following subcutaneous administration of a single dose of 40 mg in healthy individuals, Alvotech said.
A second, comparative clinical efficacy and safety trial demonstrated therapeutic equivalence in patients with severe chronic psoriasis. Alvotech said safety, efficacy, tolerability, and immunogenicity profiles were similar.
“The comprehensive AVT02 development program has demonstrated key results comparatively to the reference product, and we are extremely happy to have met our primary objectives in regard to efficacy, safety, and PK similarities,” said Kimber Poffenberger, PhD, senior vice president and global head of Regulatory Affairs for Alvotech.
For recent news about Alvotech’s commercialization partnerships for the global marketing of its biosimilar candidates, click here.