Alvotech Announces Positive Top-line Results for Switching Study Between Proposed Biosimilar AVT02 and Humira

Alvotech is showing true momentum in its goal of developing high-quality biosimilars, and these study results are another positive milestone. Patients are waiting, and we?re more committed than ever to help those living with serious chronic diseases.
R?BERT WESSMAN
Founder and Chairman of Alvotech
Completing this key milestone for Alvotech is an extremely rewarding and a positive step toward providing patients an affordable and accessible alternative to the high-concentration version of Humira.
MARK LEVICK
CEO of Alvotech
The clinical trial (AVT02-GL-302; NCT04453137) included 568 patients across approximately 30 centers in Europe. 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.
According to the FDA, an interchangeable product may be substituted for the reference product without the intervention of a prescriber. The substitution may occur at the pharmacy, much like how generic drugs are substituted for brand name drugs, subject to varying U.S. state pharmacy laws. Biosimilar and interchangeable products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. The concept of interchangeability for biosimilars was signed into law through the Biologics Price Competition and Innovation Act (BPCIA) in 2010. In order to be considered interchangeable, a biosimilar must meet additional requirements, including the execution of a ?switching study,? utilizing the reference product and biosimilar product in patients. The vast majority of states have passed laws regarding substitution for interchangeable products.