PF-06410293: An Adalimumab Biosimilar
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ADIS BIOSIMILAR BRIEF
PF‑06410293: An Adalimumab Biosimilar Arnold Lee1 · Matt Shirley1
© Springer Nature Switzerland AG 2020
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.
PF‑06410293: Key Points Biosimilar to adalimumab Similar efficacy to EU-sourced reference adalimumab in rheumatoid arthritis Generally well tolerated; similar safety profile to adalimumab Switching from reference adalimumab to PF-06410293 does not appear to impact efficacy or safety
Enhanced material for this Adis Biosimilar Brief can be found at https://doi.org/10.6084/m9.figshare.12725525. The manuscript was reviewed by: A. Becciolini, Department of Medicine, Internal Medicine and Rheumatology Unit, University Hospital of Parma, Parma, Italy; F. R. Spinelli, Dipartimento di Scienze Cliniche, Internistiche, Anestesiologiche e Cardiovascolari-Reumatologia, Sapienza University of Rome, Roma, Italy; J.A.A. Reijers, Leiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands. * Arnold Lee [email protected] 1
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1 Introduction PF-06410293 (Amsparity™ in the EU and A brilada™ in the USA) is a biosimilar of the reference monoclonal anti-TNF-α antibody adalimumab. PF-06410293 is approved by the EMA for the same indications as the reference drug (Table 1), and for similar indications as the reference drug by the US FDA [1]. PF-06410293 has similar physicochemical characteristics [2] and pharmacodynamic properties [2, 3] to those of reference adalimumab, and pharmacokinetic similarity of the agents is also supported [3] (Table 2). This article summarizes, from an EU perspective, the key features of PF-06410293 and its clinical use in the treatment of immune-mediated inflammatory diseases, focusing on rheumatoid arthritis (RA).
2 Clinical Pharmacology PF-06410293 is structurally and functionally similar to EU- and US-sourced reference adalimumab (Table 2). Pharmacokinetic similarity of
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