Alvotech Enrolls First Patient in Phase 3 Study of Proposed High-Concentration Biosimilar Adalimumab

Drug maker Alvotech announced today that it has begun enrollment for its phase 3 clinical study of AVT02, a proposed adalimumab biosimilar referencing Humira. Alvotech says that it has enrolled its first patient, and it plans to enroll approximately 400 total participants at 30 European sites in the study of AVT02 versus the reference product in patients with chronic plaque psoriasis.

A phase 1 study of the safety, tolerability, and pharmacokinetics of the proposed biosimilar is already underway in Australia.

Alvotech notes that its formulation of the proposed drug contains a high concentration of adalimumab, which it says could be more convenient for patients based on the potential for a reduced injection volume. If the drug is eventually approved, its concentration could prove to differentiate the product from a host of competitor biosimilars that are already on the market in Europe and that will enter the United States in the coming years.

Fausto Berti, PhD, Alvotech’s senior vice president and head of clinical and late-stage development, said in a statement that “the initiation of this [phase 3] study reinforces our commitment to improving the lives of patients suffering from serious chronic or life-threatening diseases by providing high-quality biosimilars. Specifically, with AVT02 containing biosimilar adalimumab at high concentration…we hope to reach future patients with a more convenient, cost-effective version of adalimumab.”

Announcement of the phase 3 study comes shortly after the Iceland-headquartered biosimilar developer announced that it had raised $300 million, through a private bond offering, to allow it to further develop its biosimilar pipeline and refinance debt.

The biosimilar developer has also recently announced partnerships with companies including Fuji Pharma, which will commercizlize Alvotech’s biosimilars in Japan, and Changchung High & New Technology Industries Group, which will sell the products in China.

In order to keep pace with its anticipated supply needs, Alvotech recently built a new state-of-the-art biopharmaceutical facility in Iceland, which was granted licensure by the Icelandic Medicines Agency, together with the Irish Health Products Regulatory Authority, in 2018. Additionally, the company owns manufacturing plants in Germany and Switzerland.