The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for AVT02 (Alvotech), a proposed biosimilar to Humira® (adalimumab; AbbVie), with high concentration (100mg/mL) dosage forms.
AVT02 is a monoclonal antibody which has been shown to be highly similar to the reference product in terms of structure and function. The BLA submission is supported by data from a phase 1 pharmacokinetics similarity study (AVT02-GL-101) and a phase 3 comparative efficacy and safety study (AVT02-GL-301). The phase 1 study compared the pharmacokinetics, safety and tolerability of AVT02 to Humira at a single dose of 40mg in 392 healthy adults. Results showed no clinically meaningful differences between AVT02 and Humira.
Additionally, the double-blind phase 3 study compared the efficacy, safety, and immunogenicity of AVT02 to Humira in 412 adults with moderate to severe chronic plaque psoriasis. Patients were randomized 1:1 to receive AVT02 or Humira with an initial loading dose of 80mg subcutaneously, followed by 40mg once every other week until week 48.
Findings from the phase 3 study showed that AVT02 met the primary end point achieving therapeutic equivalence to Humira as measured by the Psoriasis Area and Severity Index (PASI) percent improvement at week 16. Moreover, there were no clinically meaningful differences between AVT02 and Humira on the secondary end points, including safety, tolerability, immunogenicity and serum trough levels at steady state through the entire study duration.
The FDA is expected to decide on the application in September 2021.
For more information visit alvotech.com.
1. Alvotech announces that the US FDA and EMA have accepted regulatory submissions for AVT02, a proposed biosimilar to Humira® (adalimumab). [press release]. Reykjavik, Iceland: Alvotech; November 19, 2020.
2. Alvotech announces positive top-line results for two comparative studies for AVT02, a proposed biosimilar to Humira® (adalimumab). [press release]. Reykjavik, Iceland: Alvotech; May 12, 2020.