Journal article
A comparison of the immunogenicity of intravenous BAT1806, a tocilizumab biosimilar, and its reference product
- Abstract:
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Introduction: Biosimilars need to demonstrate similarity in terms of quality, pharmacokinetics (PK), efficacy, safety and immunogenicity. Here we report the outcome of a comprehensive evaluation of the immunogenicity of the biosimilar BAT1806 compared with tocilizumab reference product (TCZ).
Methods: A post-hoc analysis of study BAT1806-001-CR, a comparative PK study in healthy male volunteers (n = 129), and BAT1806-002-CR, a phase III, 52-week trial in patients with rheumatoid arthritis (n = 621). Anti-drug antibodies (ADA), ADA titres, and neutralising ADA were measured, and their impact on PK, safety, and efficacy parameters were assessed.
Results: In BAT1806-001-CR, treatment-induced ADA were observed in 37.8% of participants for the BAT1806 group, 28.6% for the EU-sourced TCZ group and 31.0% for the US-sourced TCZ group, without impact on PK and safety. In BAT1806-002-CR after 52 weeks, 28.2% of participants in the BAT1806 group developed treatment-induced ADA, compared with 24.0% in the TCZ group and 19.7% of participants who initiated TCZ and switched to BAT1806 at week 24. ADA-positive participants reported lower geometric mean serum tocilizumab trough concentrations than ADA-negative participants in all treatment groups. ADA-positive participants achieved similar efficacy outcomes to ADA-negative participants in all treatment groups. ADA were not associated with an incremental risk of treatment-emergent adverse events or hypersensitivity in any treatment group.
Conclusions: The results of these post hoc analyses did not indicate any clinically relevant differences in the immunogenicity profile of intravenously administered BAT1806 compared with TCZ.
Trial registration: ClinicalTrials.gov identifiers, NCT03606876, NCT03830203
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 1.5MB, Terms of use)
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- Publisher copy:
- 10.1007/s40744-025-00760-y
Authors
- Publisher:
- Springer
- Journal:
- Rheumatology and Therapy More from this journal
- Volume:
- 12
- Issue:
- 3
- Pages:
- 529-546
- Publication date:
- 2025-04-08
- Acceptance date:
- 2025-03-18
- DOI:
- EISSN:
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2198-6584
- ISSN:
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2198-6576
- Language:
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English
- Keywords:
- Pubs id:
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2096669
- Local pid:
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pubs:2096669
- Deposit date:
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2025-03-21
Terms of use
- Copyright holder:
- Ebbers et al.
- Copyright date:
- 2025
- Rights statement:
- Copyright © 2025, The Author(s). This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.
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