A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product.

ABSTRACT:

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 the tocilizumab reference product (TCZ).

Methods

We conducted 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 titers, and neutralizing 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

SUBMITTER: Ebbers HC 

PROVIDER: S-EPMC12084431 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature