T assays were conducted, and the mean percent relative activity is reported (see text). A dose response from a single assay of the three is presented here as representative data. e Representative nonconstrained dose?response curves of ABP 501 (red), adalimumab (US) (black), and adalimumab (EU) (blue) showing binding to FcRn. Each point is a mean of three replicates ?standard deviation. Adalimumab
T assays were conducted, and the mean percent relative activity is reported (see text). A dose response from a single assay of the three is presented here as representative data. e Representative nonconstrained dose?response curves of ABP 501 (red), adalimumab (US) (black), and adalimumab (EU) (blue) showing binding to FcRn. Each point is a mean of three replicates ?standard deviation. Adalimumab
Rm the safety and efficacy profile of ABP 501. In a phase I human pharmacokinetic study, ABP 501 has been shown to be similar to adalimumab (US) and adalimumab (EU) [26, 27]. Clinical studies designed to assess the similarity of ABP 501 relative to the adalimumab reference product for the treatment of moderate to severe plaque psoriasis [28, 29] and moderate to severe rheumatoid arthritis [30, 31]
Alimumab (US) (black), and adalimumab (EU) (blue). Each point represents results from testing a unique lot. The dotted lines represent the quality range established based on the adalimumab (US) lots tested (mean ?3 standard deviations). Adalimumab (EU) EU-authorized adalimumab, adalimumab (US) FDA-licensed adalimumab, CDC complementdependent cytotoxicityFunctional Characterization of ABP 501, Bios
Certolizumab is reduced in Crohn's disease relative to the efficacy observed with adalimumab [24, 25], which suggests that Fc-mediated effector functions may be important. Binding of mAbs to FcRn affects clearance, so a similarity assessment of biosimilars should also include sensitive methods to assess binding to FcRn. ABP 501 was shown to have similar binding to FcRn as compared with adalimumab.
Certolizumab is reduced in Crohn's disease relative to the efficacy observed with adalimumab [24, 25], which suggests that Fc-mediated effector functions may be important. Binding of mAbs to FcRn affects clearance, so a similarity assessment of biosimilars should also include sensitive methods to assess binding to FcRn. ABP 501 was shown to have similar binding to FcRn as compared with adalimumab.
Certolizumab is reduced in Crohn's disease relative to the efficacy observed with adalimumab [24, 25], which suggests that Fc-mediated effector functions may be important. Binding of mAbs to FcRn affects clearance, so a similarity assessment of biosimilars should also include sensitive methods to assess binding to FcRn. ABP 501 was shown to have similar binding to FcRn as compared with adalimumab.
Assessment of the bioactivity of adalimumab should include assessment of multiple in vitro endpoints (NFjB-dependent and NFjB-independent) and should include binding to both soluble and transmembrane TNFa. ABP 501 has been shown to be similar to adalimumab in its ability to neutralize TNFa-induced caspase activation, chemokine production, and cytotoxicity, functions inclusive of both NFjB-dependen