2020-09-21 12_21_08-PF-06410293_ An Adalimumab Biosimilar.png (133.79 kB)

PF-06410293: An Adalimumab Biosimilar

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posted on 2020-09-21, 00:25 authored by Arnold Lee, Matt Shirley

Declarations

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

Authorship and Conflict of interest 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.

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

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.