Extensive preclinical evaluation of an infliximab biosimilar candidate

Velasco-Velázquez, Marco A.; Salinas-Jazmín, Nohemí; Hisaki-Itaya, Emiliano; Cobos-Puc, Luis E.; Xolalpa, Wendy; Gonzalez, Graciela Leon de; Tenorio-Calvo, Alejandra; Piña-Lara, Nelly; Juárez-Bayardo, L. Carmina; Flores-Ortiz, Luis F.; Medina‐Rivero, Emilio; Pérez, Nestor O.; Pérez‐Tapia, Sonia Mayra

doi:10.1016/j.ejps.2017.01.038

Cited by 7 publications

(3 citation statements)

References 36 publications

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“…Image capillary isoelectric focusing (icIEF) allows the cIEF process to be “imaged” in real-time using whole-column imaging detection (WCID) technology. While, cIEF has been employed for charge profiling of biosimilar candidates of Amgen’s adalimumab (ABP 501) ( Liu et al, 2016 ) and bevacizumab (ABP 215) ( Seo et al, 2018 ), and Probiomed S.A. de C.V.’s rituximab (Kikuzubam) ( Miranda-Hernandez et al, 2015 ), etanercept (Infinitam ® ) ( Miranda-Hernández et al, 2016 ), trastuzumab-Probiomed ( López-Morales et al, 2015 ) and infliximab-Probiomed ( Velasco-Velázquez et al, 2017 ); examples of biosimilarity platforms with icIEF include Pfizer’s infliximab (PF-06438179) ( Derzi et al, 2016 ) and adalimumab (PF-06410293) ( Derzi et al, 2020 ), Zhejiang Hisun’s tocilizumab (HS628) ( Miao et al, 2017 ), Samsung Bioepis’s infliximab (SB2) ( Hong et al, 2017 ) and adalimumab (SB5) ( Lee et al, 2019 ), and Shanghai Henlius’s rituximab (HLX01) ( Xu et al, 2019 ), trastuzumab (HLX02) ( Xie et al, 2020 ) and adalimumab (HLX03) ( Zhang et al, 2020 ) ( Supplementary Table S4 ).…”

Section: Global Landscape On Biosimilar Approvalsmentioning

confidence: 99%

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Nupur

Joshi

Gulliarme

et al. 2022

Front. Bioeng. Biotechnol.

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Biopharmaceuticals are one of the fastest-growing sectors in the biotechnology industry. Within the umbrella of biopharmaceuticals, the biosimilar segment is expanding with currently over 200 approved biosimilars, globally. The key step towards achieving a successful biosimilar approval is to establish analytical and clinical biosimilarity with the innovator. The objective of an analytical biosimilarity study is to demonstrate a highly similar profile with respect to variations in critical quality attributes (CQAs) of the biosimilar product, and these variations must lie within the range set by the innovator. This comprises a detailed comparative structural and functional characterization using appropriate, validated analytical methods to fingerprint the molecule and helps reduce the economic burden towards regulatory requirement of extensive preclinical/clinical similarity data, thus making biotechnological drugs more affordable. In the last decade, biosimilar manufacturing and associated regulations have become more established, leading to numerous approvals. Biosimilarity assessment exercises conducted towards approval are also published more frequently in the public domain. Consequently, some technical advancements in analytical sciences have also percolated to applications in analytical biosimilarity assessment. Keeping this in mind, this review aims at providing a holistic view of progresses in biosimilar analysis and approval. In this review, we have summarized the major developments in the global regulatory landscape with respect to biosimilar approvals and also catalogued biosimilarity assessment studies for recombinant DNA products available in the public domain. We have also covered recent advancements in analytical methods, orthogonal techniques, and platforms for biosimilar characterization, since 2015. The review specifically aims to serve as a comprehensive catalog for published biosimilarity assessment studies with details on analytical platform used and critical quality attributes (CQAs) covered for multiple biotherapeutic products. Through this compilation, the emergent evolution of techniques with respect to each CQA has also been charted and discussed. Lastly, the information resource of published biosimilarity assessment studies, created during literature search is anticipated to serve as a helpful reference for biopharmaceutical scientists and biosimilar developers.

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Section: Global Landscape On Biosimilar Approvalsmentioning

confidence: 99%

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Nupur

Joshi

Gulliarme

et al. 2022

Front. Bioeng. Biotechnol.

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“…Для оценки биологической активности препаратов МкАТ применяют в основном методики in vitro на культурах клеток, отражающие механизм их действия в организме человека, что позволяет оценить взаимодействие МкАТ с соответствующими мишенями [6,9,18]. На рисунке 1 представлены основные механизмы действия терапевтических МкАТ 4 .…”

Section: особенности оценки биологических свойств препаратов моноклон...unclassified

“…Таблица составлена авторами по данным NIBSC18 / The table is prepared by the authors using NIBSC data18 18 https://www.nibsc.org/products/brm_product_catalogue/sub_category_listing.aspx?category=Biotherapeutics&subcategor-y=Monoclonal+Antibodies International…”

mentioning

confidence: 99%

International standards for monoclonal antibodies for assessing the biological activity of medicines: A status update

Gayderova,

Alpatova,

Lysikova

et al. 2023

Biological Products. Prevention, Diagnosis, Treatment

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Scientific relevance. The clinical effects and the expiration of patents for original (reference) biotechnological medicines based on monoclonal antibodies (mAbs) stimulated the development of biosimilar mAbs. The quality profile of a biosimilar mAb should correspond to the quality of the reference medicinal product. When demonstrating biosimilarity and determining the activity of medicines as part of batch quality control, analysts should study the biological properties of mAbs using suitable reference standards. The lack of international standards (ISs) makes mAb manufacturers use in-house reference standards. There is a risk of obtaining non-uniform quality and efficacy data because of the use of in-house reference standards, the heterogeneity and structural complexity of mAbs, and the relationship between the biological activity and efficacy of mAbs.Aim. This study aimed to analyse the relevance of and need for ISs for the biological activity of biotherapeutic mAbs and to define the role of reference medicinal products and ISs in assessing biosimilarity and testing medicines throughout their lifecycle.Discussion. This review covers the issues arising from the lack of ISs for assessing the biological activity of mAbs and the role and significance of reference products and ISs for biosimilars. The authors describe the specifics of studying the biological properties of mAbs and summarise the data on the need to develop and use ISs for the standardisation of biological tests. This review presents the results of studies on the first ISs established by the World Health Organisation to assess the biological activity of mAbs; these results suggest the need to standardise mAbs using ISs to ensure the quality, safety, and efficacy of mAb therapy.Conclusions. The use of ISs for mAbs plays a key role in harmonising biological activity assessments. Publicly available ISs serve as primary standards for the calibration of secondary reference materials. Moreover, ISs are required for the harmonisation of activity evaluation (in IU) between laboratories and for the consistency of the activity of various medicinal products from different manufacturers that share the same INN. The use of ISs by mAb manufacturers will contribute to ensuring the quality of mAbs and clinical monitoring of the effectiveness of their use.

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Bioassays for the Evaluation of Target Neutralization and Complement-Dependent Cytotoxicity (CDC) of Therapeutic Antibodies

Salinas-Jazmín

Medina‐Rivero

Velasco-Velázquez

2021

Methods in Molecular Biology

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Extensive preclinical evaluation of an infliximab biosimilar candidate

Cited by 7 publications

References 36 publications

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

International standards for monoclonal antibodies for assessing the biological activity of medicines: A status update

Bioassays for the Evaluation of Target Neutralization and Complement-Dependent Cytotoxicity (CDC) of Therapeutic Antibodies

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