PF-06410293: An Adalimumab Biosimilar.
Arnold LeeMatt ShirleyPublished in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy (2021)
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.
Keyphrases
- rheumatoid arthritis
- juvenile idiopathic arthritis
- disease activity
- hidradenitis suppurativa
- ulcerative colitis
- ankylosing spondylitis
- interstitial lung disease
- end stage renal disease
- chronic kidney disease
- ejection fraction
- randomized controlled trial
- open label
- bone marrow
- stem cells
- cell therapy
- smoking cessation
- placebo controlled