Alvotech, today announced top-line results from a randomized study in patients that demonstrate bioequivalence of repeated switches between administration of Humira® (adalimumab) and Alvotech’s high-concentration biosimilar candidate, AVT02 (100 mg/mL) to administration of Humira without switching. Further, no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and the reference product cohort.
The purpose of the switching study is to support the potential approval of AVT02 by the U.S. Food and Drug Administration as an interchangeable product with Humira. Alvotech is the only known company that has both developed and submitted a filing for a high-concentration biosimilar candidate to Humira, as well as conducted a switching study to support potential approval as an interchangeable product. Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is the exclusive strategic partner for the commercialization of AVT02 in the United States.
Adalimumab inhibits Tumor Necrosis Factor, which is a protein in the body that causes inflammation. Adalimumab is used to treat certain inflammatory conditions. Humira recorded sales of about US$20 billion in 2018, making it the largest-selling biologic in the world.Today, over 80 percent of the usage of Humira in the United States is the high-concentration strengths.
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.