On June 15, 2021 Alvotech announced that data collection has been completed from the last of its 568 clinical trial study participants in AVT02-GL-302, a switching study for AVT02, the company’s biosimilar to high concentration (100mg/mL) Humira®. The switching study compared the pharmacokinetics, efficacy, safety, and immunogenicity of AVT02 (40 mg/mL) to subcutaneous Humira® (40 mg/mL) in patients with moderate to severe chronic plaque psoriasis. The clinical trial was conducted at multiple locations across Europe. Successful demonstration of interchangeability as part of AVT02’s Biologics License Application (BLA) would allow pharmacists to substitute AVT02 for Humira® without the approval of the health care professional who prescribed Humira®.
Both the U.S. FDA and the European Medicines Agency (EMA) have accepted Alvotech’s regulatory submissions for AVT02. The company reported that a decision from the FDA regarding the company’s BLA for AVT02 is expected in September of 2021 and that a decision from the EMA for the AVT02 European Marketing Authorization Application (MAA) is anticipated in the fourth quarter of 2021.
As we previously reported, there is ongoing litigation in the Northern District of Illinois and in the Eastern District of Virginia regarding the BLA for AVT02.