Di Santo Andrea, Marrani Edoardo, Gallo Carmen, Errante Fosca, Maniscalco Valerio, Papini Anna Maria, Simonini Gabriele, Rovero Paolo, Real Fernandez Feliciana
Interdepartmental Research Unit of Peptide and Protein Chemistry and Biology (Peptlab), University of Florence, 50019 Sesto Fiorentino, Italy.
Department of Neurosciences, Psychology, Drug Research and Child Health (NeuroFarBa), University of Florence, 50019 Sesto Fiorentino, Italy.
Biosensors (Basel). 2025 Apr 29;15(5):278. doi: 10.3390/bios15050278.
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, and the biosimilars GP2017 (Hyrimoz) and SB5 (Imraldi). 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 values for purified AAA from patients treated with biosimilars GP2017 (Hyrimoz) or SB5 (Imraldi) were comparable across all formulations tested, including the originator Humira. AAA interacted with Humira, Hyrimoz, and Imraldi with similar apparent affinity (10 M > K > 10 M); slight variations have been observed among patients, less among biosimilars. The similarity in K values across biosimilars and the originator supports the notion that, at the level of immunogenicity, biosimilars can be considered clinically comparable to the originator.
阿达木单抗生物类似药在临床实践中的使用越来越普遍，这反映出它们作为参照生物制剂的治疗替代方案越来越被接受且疗效良好。然而，关于患者体内产生的抗阿达木单抗抗体（AAA）与不同阿达木单抗生物类似药之间分子相互作用的研究仍然有限。本研究旨在表征来自幼年特发性关节炎患儿的纯化AAA与三种阿达木单抗制剂之间的动力学相互作用：原研药修美乐（Humira），以及生物类似药GP2017（Hyrimoz）和SB5（Imraldi）。为此，将阿达木单抗制剂固定在金芯片上，然后使纯化的AAA流过，以使用表面等离子体共振（SPR）技术进行进一步的动力学分析。结果表明，在所有测试制剂中，包括原研药修美乐，接受生物类似药GP2017（Hyrimoz）或SB5（Imraldi）治疗患者的纯化AAA的K值相当。AAA与修美乐、Hyrimoz和Imraldi的相互作用具有相似的表观亲和力（10⁻⁶ M > K > 10⁻⁷ M）；在患者之间观察到轻微差异，在生物类似药之间差异较小。生物类似药与原研药的K值相似，这支持了在免疫原性水平上生物类似药在临床上可被视为与原研药相当的观点。
