Abstract
GP2017 (adalimumab) is a biosimilar anti-TNF-α antibody. It is approved in the EU for use in all indications for which reference adalimumab is approved. GP2017 has similar physicochemical and functional properties to those of reference adalimumab, and the pharmacokinetic similarity of the agent has been shown in healthy male volunteers. GP2017 demonstrated clinical efficacy equivalent to that of reference adalimumab in patients with moderate to severe plaque psoriasis or rheumatoid arthritis; the tolerability, safety and immunogenicity profiles of the two agents were also similar. Multiple switching between GP2017 and reference adalimumab (up to four times) had no impact on efficacy, tolerability or immunogenicity. The role of reference adalimumab in the management of autoimmune inflammatory conditions is well established and GP2017 provides an effective biosimilar alternative for patients requiring adalimumab therapy.
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The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of GP2017 was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit. Young-A Heo is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
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The manuscript was reviewed by: B. Jilma, Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria; P. Kurki, Department of Clinical Immunology, University of Helsinki, Helsinki, Finland.
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Heo, YA. GP2017: An Adalimumab Biosimilar. BioDrugs 32, 635–638 (2018). https://doi.org/10.1007/s40259-018-0318-x
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DOI: https://doi.org/10.1007/s40259-018-0318-x