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.
Le lots) and biofunctional parameters. The biofunctional parameters tested include an assessment of both binding and function within both the Fab and Fc portions of the mAb.Acknowledgments The authors thank Abhishek Mathur for scientific and technical contributions to the reported data and Jennifer Liu, Jill Crouse-Zeineddini, and Scott Kuhns for guidance on overall similarity assessment strategy.
N of the mAb were shown to be able to discriminate a thermally degraded sample (data not shown), demonstrating that the utilized assays are sensitive to detect differences in activity, if they did exist. It is well established that IgG1 mAbs are efficient mediators of effector function, and are able to bind to many of the known FccRs. A sensitive comparison of these Fcdependent activities is impor
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