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THU0145 Pharmacokinetics and Safety of GP2015, A Proposed Etanercept Biosimilar, and Etanercept Originator Product in Healthy Male Subjects: A Randomised Two-Way Crossover Study
  1. M. Afonso,
  2. S. Sanguino Heinrich,
  3. J. Poetzl,
  4. H. Woehling
  1. Global clinical development, Biopharmaceuticals, Hexal AG, Holzkirchen, Germany


Background GP2015 is a proposed etanercept (tumor necrosis factor inhibitor) biosimilar.

Objectives To compare the pharmacokinetics (PK) and safety of GP2015 and etanercept originator product (EU-authorised) in healthy subjects.

Methods Healthy subjects (N=54) were randomised to receive a single 50 mg subcutaneous (sc) injection of GP2015 or etanercept originator product, followed by a wash-out period of at least 35 days, and a single 50 mg sc injection of originator product or GP2015, respectively. Subsequent follow up was 28 days. The primary PK parameters were normalised by the protein content of the administered dose before fitting in the analysis of variance model (dose normalised PK analysis). Bioequivalence between GP2015/etanercept originator product for primary PK parameters [maximum observed serum concentration (Cmax), area under the serum concentration-time curve measured from the time of dosing to the last measurable concentration (AUC0-tlast) and AUC measured from the time of dosing and extrapolated to infinity (AUC0-inf)] was demonstrated if the 90% confidence intervals (CIs) for the ratio of geometric means were completely contained within the predefined bioequivalence limits of 0.80–1.25.

Results The 90% CIs for the ratios of geometric means of dose normalised primary PK parameters (Cmax, AUC0-tlast and AUC0-inf) were within the interval of 0.80–1.25 (Table). For the respective nominal dose (not dose normalised) primary PK parameters, the 90% CIs of the ratios of geometric means were also within the interval of 0.80–1.25 (Table). The most common AEs regardless of relationship to study drug were neutropenia [GP2015, n=7 (13%); originator product, n=8 (14.8%)], headache [GP2015, n=5 (9.3%); originator product, n=5 (9.3%)] and nasopharyngitis [GP2015, n=4 (7.4%); originator product, n=4 (7.4%)]. All treatment-related AEs were of mild or moderate intensity. No serious AEs and deaths occurred during the study. Three subjects had low titer and non-neutralising anti-drug antibodies (ADAs) at the 28-day follow-up visit (treatment sequence GP2015/etanercept originator product).

Conclusions This study demonstrated PK bioequivalence between GP2015, a proposed etanercept biosimilar and the etanercept originator product with no relevant differences in safety. The safety and immunogenicity profiles observed in this study are consistent with previous reports on etanercept originator product.

Disclosure of Interest M. Afonso Employee of: Hexal AG, affiliate of Novartis, S. Sanguino Heinrich Employee of: Hexal AG, affiliate of Novartis, J. Poetzl Employee of: Hexal AG, affiliate of Novartis, H. Woehling Shareholder of: Hexal AG, affiliate of Novartis, Employee of: Hexal AG, affiliate of Novartis

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