Anti-Adalimumab Antibodies Purified from Juvenile Idiopathic Arthritis Patients: Kinetic Characterization Among Biosimilars

The use of adalimumab biosimilars has become increasingly common in clinical practice, reflecting their growing acceptance and efficacy as therapeutic alternatives to reference biologics. However, studies investigating the molecular interactions between anti-adalimumab antibodies (AAA) elicited in patients and different adalimumab biosimilars remain limited. This study aims to characterize the kinetic interactions between purified AAA from pediatric patients with Juvenile Idiopathic Arthritis and three adalimumab formulations: the originator Humira<sup>®</sup>, and the biosimilars GP2017 (Hyrimoz<sup>®</sup>) and SB5 (Imraldi<sup>®</sup>). For this purpose, adalimumab formulations were immobilized on a gold chip, and purified AAA were flowed to perform further kinetic analysis using the surface plasmon resonance (SPR) technology. Results showed that the K<sub>D</sub> values for purified AAA from patients treated with biosimilars GP2017 (Hyrimoz<sup>®</sup>) or SB5 (Imraldi<sup>®</sup>) were comparable across all formulations tested, including the originator Humira<sup>®</sup>. AAA interacted with Humira<sup>®</sup>, Hyrimoz<sup>®</sup>, and Imraldi<sup>®</sup> with similar apparent affinity (10<sup>-9</sup> M > K<sub>D</sub> > 10<sup>-10</sup> M); slight variations have been observed among patients, less among biosimilars. The similarity in K<sub>D</sub> values across biosimilars and the originator supports the notion that, at the level of immunogenicity, biosimilars can be considered clinically comparable to the originator.

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Publication Details

Journal
Biosensors
Published
2025-04-29
DOI
https://doi.org/10.3390/bios15050278
Primary Topic
Biosimilars and Bioanalytical Methods
Type
article
Field-Weighted Citation Impact
0.00

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article

Anti-Adalimumab Antibodies Purified from Juvenile Idiopathic Arthritis Patients: Kinetic Characterization Among Biosimilars

Gabriele Simonini, Anna Maria Papini, Paolo Rovero, Andrea Di Santo et al.
Biosensors
Biosimilars and Bioanalytical Methods
article

Anti-Adalimumab Antibodies Purified from Juvenile Idiopathic Arthritis Patients: Kinetic Characterization Among Biosimilars

Gabriele Simonini, Anna Maria Papini, Paolo Rovero, Andrea Di Santo, Clarisse de Almeida Gallo, Feliciana Real‐Fernández, Valerio Maniscalco, Edoardo Marrani, Fosca Errante
article en

Abstract

The use of adalimumab biosimilars has become increasingly common in clinical practice, reflecting their growing acceptance and efficacy as therapeutic alternatives to reference biologics. However, studies investigating the molecular interactions between anti-adalimumab antibodies (AAA) elicited in patients and different adalimumab biosimilars remain limited. This study aims to characterize the kinetic interactions between purified AAA from pediatric patients with Juvenile Idiopathic Arthritis and three adalimumab formulations: the originator Humira<sup>®</sup>, and the biosimilars GP2017 (Hyrimoz<sup>®</sup>) and SB5 (Imraldi<sup>®</sup>). For this purpose, adalimumab formulations were immobilized on a gold chip, and purified AAA were flowed to perform further kinetic analysis using the surface plasmon resonance (SPR) technology. Results showed that the K<sub>D</sub> values for purified AAA from patients treated with biosimilars GP2017 (Hyrimoz<sup>®</sup>) or SB5 (Imraldi<sup>®</sup>) were comparable across all formulations tested, including the originator Humira<sup>®</sup>. AAA interacted with Humira<sup>®</sup>, Hyrimoz<sup>®</sup>, and Imraldi<sup>®</sup> with similar apparent affinity (10<sup>-9</sup> M > K<sub>D</sub> > 10<sup>-10</sup> M); slight variations have been observed among patients, less among biosimilars. The similarity in K<sub>D</sub> values across biosimilars and the originator supports the notion that, at the level of immunogenicity, biosimilars can be considered clinically comparable to the originator.

BiosensorsVol. 15(5)
Meyer Children's Hospital (IT), Institute for the Chemistry of OrganoMetallic Compounds (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), National Research Council (IT), Hospital of Prato (IT), University of Florence (IT)
European Commission
Openalex Percentile: Top 90%
Biosimilars and Bioanalytical Methods
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