AVT02: An Adalimumab Biosimilar.

AVT02 (Hukyndra®, Libmyris®) is a biosimilar of the reference anti-tumour necrosis factor alpha monoclonal antibody adalimumab. It is approved for use in all indications for which reference adalimumab is approved. AVT02 has similar physicochemical and pharmacodynamic properties to those of reference adalimumab, and the pharmacokinetic similarity of the agent has been shown in healthy adult subjects. AVT02 demonstrated clinical efficacy similar to that of reference adalimumab in patients with chronic plaque psoriasis, and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of AVT02 were similar to those of reference adalimumab. Switching from reference adalimumab to AVT02 appeared to have no impact on efficacy, safety or immunogenicity. The role of reference adalimumab in the management of immune-mediated inflammatory diseases is well established and AVT02 provides an effective biosimilar alternative for patients requiring adalimumab therapy.