Alvotech Demonstrates Therapeutic Equivalence for Stelara Biosimilar Candidate AVT04

Alvotech, a global biotech company focused on biosimilar medicines, has announced positive outcomes from a confirmatory clinical study for AVT04, its proposed biosimilar to Stelara® (ustekinumab). The study met its primary endpoint, demonstrating therapeutic equivalence between Alvotech's biosimilar candidate and the reference product.

The randomized, double-blind, multicenter study (AVT04-GL-301) involved 581 patients with moderate to severe chronic plaque psoriasis across four European countries. The primary efficacy endpoint, measured by the percentage improvement in Psoriasis Area and Severity Index (PASI) score from baseline at Week 12, was successfully achieved. No clinically meaningful differences in safety were observed through week 28.

This development positions Alvotech as the second company to report positive patient study results for a Stelara® biosimilar candidate. Stelara® generated over $9 billion in worldwide net sales in 2021, highlighting the market potential for biosimilar alternatives. Alvotech has established strategic partnerships for commercialization in key markets, including with Teva Pharmaceuticals in the United States and STADA in Europe.

Alvotech's pipeline includes eight products and candidates, such as AVT02, a biosimilar to Humira®, and AVT04. The company utilizes an integrated platform for development and manufacturing, aiming to deliver cost-effective biosimilar medicines to patients globally.