GP2017, an adalimumab biosimilar: pharmacokinetic similarity to its reference medicine and pharmacokinetics comparison of different administration methods

ABSTRACTBackground: To compare the pharmacokineticsof Sandoz biosimilar adalimumab(GP2017) with reference adalimumab(Humira) in healthy volunteers (PK similarity study) and to compare the pharmacokineticsof GP2017 administered by autoinjector(AI) or prefilled syringe (PFS; delivery study).Methods: Healthy male subjects were randomized to receive a single 40 mg subcutaneous injectionof GP2017, US-licensed or EU-authorized reference adalimumab(US/EU-Humira; PK similarity study) or a single 40 mg subcutaneous injectionof GP2017 via AI or PFS (delivery study). Pharmacokinetics, safety, and immunogenicity were assessed over 72 days post-injection.Results: The geometric mean ratios (90% confidence intervals) for Cmaxand AUC0–inf were 1.05 (0.99–1.11) and 1.04 (0.96–1.13) for GP2017/EU-Humira and 1.00 (0.94–1.06) and 1.08 (1.00–1.18) for GP2017/US-Humira, all within the prespecified margin of 0.80–1.25 (PK similarity study). Pharmacokineticparameters of GP2017 matched between AI and PFS (delivery study...