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

ABSTRACT

Background: 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 C_max and AUC_0–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

KEYWORDS:

• Adalimumab
• biosimilar
• delivery
• device
• GP2017
• pharmacokinetics
• PK similarity

Declaration of interest

This work has been previously presented in part at the Annual Meeting of the American College of Rheumatology, San Diego, CA; Nov 3–8, 2017 (poster presentation, Abstract 2443) and the European League Against Rheumatism, London, UK; Jun 8–11, 2017 (poster presentation, Abstract 638).

O. Richter, L. Lemke, H. Haliduola, E. Schuck, J. Poetzl, and J. Jauch-Lembach are employees of Hexal AG/Sandoz. A. Skerjanec is an employee of Sandoz AG. R. Fuhr and T. Koernicke are employees of PAREXEL International GmbH. M. Velinova is an employee of PRA Health Sciences. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Data availability

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.

Author contributions

All authors were involved in the conception and design of the study or in the analysis and interpretation of the data. All authors reviewed and revised the manuscript and provided their approval of the final version of the manuscript. All authors agree to be accountable for all aspects of the work.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

These studies were sponsored by Sandoz Biopharmaceuticals/Hexal AG. Editorial support was provided by Olga Ucar of Spirit, sponsored by Sandoz Biopharmaceuticals/Hexal AG.