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

Oliver von Richtera, Lena Lemkea, Halimuniyazi Haliduolaa, Rainard Fuhrb, Thomas Koernickeb, Ellen Schucka, Maria Velinovac, Andrej Skerjanecd, Johann Poetzla & Julia Jauch-Lembach*aa Global Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz company), Holzkirchen, Germanyb PAREXEL International GmbH, Berlin, Germanyc PRA Health Sciences, Zuidlaren, Netherlandsd Clinical Pharmacology Biosimilars, Sandoz AG, Novartis Company, Basel, SwitzerlandCONTACT Julia Jauch-Lembach julia.jauch-lembach@sandoz.com Global Clinical Development, Sandoz International GmbH, Industriestrasse 25, Holzkirchen 83607, GermanyABSTRACTBackground: To compare the pharmacokinetics of Sandoz biosimilar adalimumab (GP2017) with reference adalimumab (Humira) in healthy volunteers (PK similarity study) and to compare the pharmacokinetics of GP2017 administered by autoinjector (AI) or prefilled syringe (PFS; delivery study).Methods: Healthy male subjects were randomized to receive a single 40 mg subcutaneous injection of GP2017, US-licensed or EU-authorized reference adalimumab (US/EU-Humira; PK similarity study) or a single 40 mg subcutaneous injection of 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 Cmax and 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). Pharmacokinetic parameters of GP2017 matched between AI and PFS (delivery study). Safety and immunogenicity were similar across groups in both studies.Conclusion: PK similarity between GP2017, EU- and US-Humira was demonstrated. The safety profile of GP2017 was consistent with previous reports for Humira. These results contribute to the ‘totality-of-the-evidence’ supporting biosimilarity of GP2017 to Humira. PK and tolerability were equivalent for GP2017 dosed by AI or PFS.Trial registration: PK similarity study EudraCT no. 2015-000579-28; Delivery study: EudraCT no. 2014–002879-29