Comparative Immunogenicity Assessment of Biosimilars

Schreitmüller, Thomas; Barton, Bettina; Zharkov, Artem; Bakalos, Georgios

doi:10.2217/fon-2018-0553

Cited by 22 publications

(26 citation statements)

References 33 publications

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“…With multiple approaches possible, different technologies should be compared to ensure assay suitability, as conducted for CT-P13 [47]. However, debate continues regarding optimal assay design, with variations in assays used leading to extensive variability in reported immunogenicity and posing a challenge for interstudy comparability [48,49]: for infliximab treatment, a recently published systematic review highlighted that reports of ADA-positive patients ranged from 0 to 65.3% [50].…”

Section: Key Pointsmentioning

confidence: 99%

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Kim

Alten

Avedano³

et al. 2020

Drugs

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Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars-biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators-can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.

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Section: Key Pointsmentioning

confidence: 99%

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Kim

Alten

Avedano³

et al. 2020

Drugs

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“…Given the assay complexity and variability, caution should be taken when interpreting parameters (e.g., binding kinetics) derived from biological assays. Therefore, current biological assays have some major limitations when used for the comparison of a potential biosimilar product and reference product [44]. The reduction in assay sensitivity, caused by the intrinsic assay heterogeneity, potentially reduces the chances of finding differences in biological activity between the proposed biosimilar product and the reference product.…”

Section: Limitations In the Biological Characterization Of Glycansmentioning

confidence: 99%

“…Therefore, different assay formats and different receptors (e.g., TNFR, FcyR) are generally used to analyze specific biological products depending on their MoA [29]. The determination of the appropriate biological assay on a case-bycase basis, provides a major hurdle for regulatory agencies when creating harmonized methods for the functional evaluation of biosimilarity [44,46].…”

Section: Limitations In the Biological Characterization Of Glycansmentioning

confidence: 99%

Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implications

Duivelshof

Jiskoot

Beck

et al. 2019

Analytica Chimica Acta

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License: Article 25fa pilot End User Agreement This publication is distributed under the terms of Article 25fa of the Dutch Copyright Act (Auteurswet) with explicit consent by the author. Dutch law entitles the maker of a short scientific work funded either wholly or partially by Dutch public funds to make that work publicly available for no consideration following a reasonable period of time after the work was first published, provided that clear reference is made to the source of the first publication of the work. This publication is distributed under The Association of Universities in the Netherlands (VSNU) 'Article 25fa implementation' pilot project. In this pilot research outputs of researchers employed by Dutch Universities that comply with the legal requirements of Article 25fa of the Dutch Copyright Act are distributed online and free of cost or other barriers in institutional repositories. Research outputs are distributed six months after their first online publication in the original published version and with proper attribution to the source of the original publication. You are permitted to download and use the publication for personal purposes. All rights remain with the author(s) and/or copyrights owner(s) of this work. Any use of the publication other than authorised under this licence or copyright law is prohibited. If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons.

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“…Un biosimilar es un producto biológico o biotecnológico, el cual es altamente similar al medicamento biológico/biotecnológico de referencia. Un biosimilar no muestra diferencias significativas en términos de calidad, seguridad, eficacia (5) e inmunogenicidad (6) . Estas características son demostradas por evaluaciones rigurosas de autoridades reguladoras de referencia como FDA o EMA (7) .…”

Section: Introductionunclassified

Registro sanitario de medicamentos biológicos y biotecnológicos en América Latina

2021

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Introducción: los medicamentos biológicos se definen como productos cuyos ingredientes activos son producidos por una fuente biológica, mientras que un producto biotecnológico se desarrollar a partir del aislamiento de un gen de interés y su clonación.Método: se realizó un estudio comparativo de las regulaciones vigentes a julio de 2020 relacionadas con medicamentos biológicos y biotecnológicos de los países de Centroamérica y el Caribe que actualmente disponen de un marco regulatorio para su registro, con respecto a aquellas de Chile y Brasil.Resultados: existen diferencias relevantes en diversos aspectos. Dentro de la información general solicitada se encontraron variaciones para las definiciones de Autoridad Reguladora Estricta, producto biotecnológico, producto de referencia y producto innovador. También se hallaron divergencias para la información no clínica y clínica solicitada, y los programas de Farmacovigilancia. Para productos biosimilares se distinguieron particularidades referentes a su definición y la de ejercicio de biosimilitud, así como para aspectos propios de su utilización como lo son la extrapolación de indicaciones y la sustitución automática o intercambiabilidad. Finalmente, para su etiquetado se requiere mayor estudio por parte de las autoridades sanitarias.Conclusiones: una vez realizada la revisión de la normativa respecto al registro sanitario de productos biológicos y biotecnológicos en nueve países de América Latina, se encontró que la información solicitada no se halla homologada.

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Comparative Immunogenicity Assessment of Biosimilars

Cited by 22 publications

References 33 publications

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implications

Registro sanitario de medicamentos biológicos y biotecnológicos en América Latina

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