Comparison of the Pharmacokinetics, Safety, and Tolerability of the Autoinjector (AI) and Pre-Filled Syringe (PFS) of SB4 in Healthy Subjects

Abstract

Purpose

SB4 is an etanercept biosimilar, approved by the European Commission (EC) and the US Food and Drug Administration (FDA) following a demonstration of equivalent efficacy and safety and comparable quality data to the reference product. This study aimed to demonstrate equivalent pharmacokinetic (PK) profiles, safety, and tolerability between SB4 autoinjector (AI) and SB4 pre-filled syringe (PFS).

Patients and methods

This was an open-label, two-period, two-sequence, single-dose, cross-over study to evaluate bioequivalence of PK profiles, safety, and tolerability between SB4 AI and PFS in healthy adults. Treatment periods were separated by 14 days resulting in a 35-day washout between investigational product (IP) administration in Periods 1 and 2.

Results

A total of 50 subjects were randomized: 24 subjects in Sequence I and 26 in Sequence II, and 6 subjects discontinued from the study. The primary PK endpoints including area under the concentration–time curve from time zero to infinity (AUC_inf) and to the last quantifiable concentration (AUC_last), and maximum serum concentration (C_max) were all within the equivalence margin of 80.00–125.00%. Safety and tolerability were comparable between the two treatments.

Conclusion

PK profiles showed that SB4 AI and PFS were bioequivalent in healthy subjects. Safety assessment was also comparable between the two treatments.

Keywords:

• biosimilar
• etanercept
• bioequivalence
• autoinjector
• pre-filled syringe

Acknowledgments

Medical writing assistance was provided by Gihyun Myung, MD, an employee of Samsung Bioepis Co., Ltd.

Ethics Approval and Informed Consent

This study was approved by the Independent Ethics Committee (IEC) of the foundation Beoordeling Ethiek Biomedisch Onderzoek of The Netherlands and conducted in accordance with the Declaration of Helsinki and was approved by an ethics committee. All subjects provided written informed consent.

Data Sharing Statement

Upon request, and subject to certain criteria, conditions and exceptions, Samsung Bioepis will provide access to individual de-identified participant data. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply. The proposals should be directed to the corresponding author. To gain access, data requestors must enter into a data access agreement with Samsung Bioepis.

Disclosure

Donghoon Shin, Younsoo Kim, and Ahra Go are employees of Samsung Bioepis Co., Ltd.

The authors report no other conflicts of interest in this work.