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Differential immunogenicity of biosimilar monoclonal antibodies: overrated and overemphasized?
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DOI：10.1016/j.drudis.2026.104695.png)
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Abstract
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• Monoclonal antibodies (mAbs) as biologics/biosimilars have changed the landscape of selected chronic inflammatory conditions and oncology therapy. • Approved biosimilars are equivalent versions of biologics with no demonstrable evidence of clinically meaningful differences in efficacy, safety and immunogenicity. • The perception of risk of clinically meaningful adverse differential immunogenicity for biosimilar-mAbs offsets their adoption and this comes at a cost to patients and public health. • Accounting for the regulatory requirements of sequence homology and analytical similarity, a materially elevated risk of differential immunogenicity for bs-mAb is not to be contended. • This is amply reflected in the extensive clinical evidence accrued to date.
Keywords:
biosimilar monoclonal antibodies
immunogenicity
clinical evidence
regulatory requirements
therapeutic equivalence
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