PF-06410293: An Adalimumab Biosimilar

<div><p><b>Declarations</b></p><p><b>Funding</b> The preparation of this review was not supported by any external funding.</p><p><b>Authorship and Conflict of interest</b><b><i> </i></b>A. Lee and M. Shirley are salaried employees of Adis International Ltd/Springer Nature, and declare no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.</p><p><b> </b></p><p> </p><p><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</b> Not applicable</p></div><div><br></div>Additional information about this Adis Drug Review can be found <b><a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a></b><div><br></div><div><p><b>Abstract </b></p> <p>PF-06410293 (Amsparity^™/Abrilada^™) is a biosimilar of the anti-tumor necrosis factor (TNF)-α antibody adalimumab. It is approved for use in all indications for which adalimumab is approved, including inflammatory joint diseases (e.g. rheumatoid arthritis), uveitis, psoriasis and Crohn's disease. PF-06410293 has similar physicochemical and pharmacodynamic properties to those of EU- and US-sourced reference adalimumab, and the pharmacokinetic similarity of the agents is supported. PF-06410293 demonstrated therapeutic equivalence to EU-sourced reference adalimumab in patients with rheumatoid arthritis, and was generally well tolerated in this population. The tolerability, efficacy, safety and immunogenicity profiles of PF-06410293 were similar to those of EU-sourced reference adalimumab, and switching from reference adalimumab to PF-06410293 appeared to have no impact on safety or efficacy. The role of adalimumab in the management of immune-mediated inflammatory diseases is well established and PF-06410293 provides an effective biosimilar alternative for patients requiring adalimumab therapy.</p><p></p><p>© Springer Nature Switzerland AG 2020</p><br></div>