A Phase I, Randomized, Double-Blind, Single-Dose, Parallel-Group Study to compare Pharmacokinetic Similarity, Safety, and Immunogenicity Between BAT2506 and Golimumab in Healthy Chinese Male Subjects

ABSTRACT

Background: To compare the pharmacokinetic (PK) profile, safety, and immunogenicity between golimumab and the biosimilar BAT2506 in healthy Chinese male subjects.

Research design and methods: A total of 180 healthy male subjects were recruited for this randomized, double-blinded, single-dose, parallel study. They received 50 mg BAT2506 or golimumab (1:1 ratio) by single subcutaneous injection. The evaluation index included maximum plasma concentration (C_max), area under the plasma concentration-time curve (AUC_0-t, AUC_0-∞), safety, and immunogenicity.

Results: The results showed that the 90% confidence interval (CI) of the geometric mean ratio (GMR) of BAT2506 to reference drug (golimumab) for C_max, AUC_0–∞ and AUC_0-t were 99.26% (90.59–108.76%), 102.06% (93.31%–111.64%), and 102.05% (93.51–111.38%), respectively. All 90% CIs were within the range of 80–125% range, which is the limitation of the equivalence margin. Furthermore, similarity of treatment-emergent adverse events was also found between the two drugs. A total of 14 subjects (7.8%) developed anti-drug antibody after administration.

Conclusions: Our study confirmed the PK similarity between BAT2506 and golimumab, and showed good tolerance of BAT2506 in healthy subjects. There were no differences in safety and immunogenicity between the two drugs. Therefore, BAT2506 meets the criteria for biosimilarity to golimumab.

Trial registration: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04152759).

KEYWORDS:

• BAT2506
• biosimilar
• safety
• pharmacokinetics
• immunogenicity

Article highlights

• The biosimilarity of BAT2506, a new biological product, was determined by comparing pharmacokinetics, safety, and immunogenicity between BAT2506 and SIMPONI® (golimumab).

• BAT2506 is pharmacokinetically similar to the originator golimumab and has good tolerance in healthy subjects.

• There were no differences in safety and immunogenicity between BAT2506 and golimumab.

Acknowledgments

The authors appreciate the participation of volunteers and the contribution of staff to this trial. The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04152759).

Author contributions

M Wu and Y Ding performed a review of the topic, and wrote and revised the manuscript. H Zhang took part in analyzing pharmacokinetics data. J Sun, D Wu, J Xu drafted a part of the manuscript. J Wei, Z Wang, J Yu and S Li took part in the analysis and interpretation of data, and prepared all figures and tables. Y Ding contributed by writing the manuscript and provided critical revision. All the authors approved the final version of the manuscript and agreed to be accountable for all aspects of the work.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Declaration of interest

J Wei, H Wang, C Yu and S Li are the employees of Bio-Thera Solutions, Ltd. 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.

Additional information

Funding

This project was financially sponsored by the following programs: National Major Scientific and Technological Special Project for Significant New Drug Developmentduring the Thirteenth Five-Year Plan Period of China [No. 2017ZX09304004, 2017ZX09101001-002-004]; the National Natural Science Foundation of China [No. 81602897].