AVT02: An Adalimumab Biosimilar

  

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest Connie Kang is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content. During the peer review process, the manufacturer of AVT02 was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

AVT02 (Hukyndra^®, Libmyris^®) is a biosimilar of the reference anti-TNFα 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, and switching from reference adalimumab and AVT02 appeared to have no impact on safety or efficacy. 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. 

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