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Evaluation of the Structural, Physicochemical, and Biological Characteristics of SB11, as Lucentis(®) (Ranibizumab) Biosimilar

INTRODUCTION: SB11 was recently approved as a ranibizumab biosimilar by the US Food and Drug Administration (FDA) and the European Commission (EC) as a therapy for retinal vascular disorders under the brand name Byooviz™. This study was performed to assess the analytical similarity between SB11 and...

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Autores principales: Kim, Eunji, Han, Jihyeon, Chae, Yunjung, Park, Hyerim, Kim, Saerom, Kim, Seokkyun, Lee, Jungmin, Kim, Beom Chan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8927571/
https://www.ncbi.nlm.nih.gov/pubmed/35084693
http://dx.doi.org/10.1007/s40123-022-00453-7
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author Kim, Eunji
Han, Jihyeon
Chae, Yunjung
Park, Hyerim
Kim, Saerom
Kim, Seokkyun
Lee, Jungmin
Kim, Beom Chan
author_facet Kim, Eunji
Han, Jihyeon
Chae, Yunjung
Park, Hyerim
Kim, Saerom
Kim, Seokkyun
Lee, Jungmin
Kim, Beom Chan
author_sort Kim, Eunji
collection PubMed
description INTRODUCTION: SB11 was recently approved as a ranibizumab biosimilar by the US Food and Drug Administration (FDA) and the European Commission (EC) as a therapy for retinal vascular disorders under the brand name Byooviz™. This study was performed to assess the analytical similarity between SB11 and reference products from the European Union (EU-ranibizumab) and United States (US-ranibizumab). METHODS: A comprehensive structural, physicochemical, and biological characterization was performed utilizing state-of-the-art analytical methods. Comparisons included the following: primary structure related to amino acid sequence and post-translational modifications; higher order structure; product-related substances and purity/impurity including size and charge variants. In addition, biological characterization included a series of mechanism of action (MoA)-related bioassays such as vascular endothelial growth factor (VEGF)-A binding assay (VEGF-A 165 and its isoforms), cell-based VEGF-A 165 neutralization assay, and anti-proliferation assay using human umbilical vein endothelial cells (HUVEC). RESULTS: The amino acid sequence of SB11 was identical to that of reference products, and post-translational modification profiles and higher order structures of SB11 were shown to be indistinguishable from the reference products. Product-related size and charge variants and aggregates were also similar. Using a broad range of VEGF-related functional assays, we demonstrated that SB11 has similar biological properties to reference products in VEGF-A binding activities (VEGF-A 165 and isoforms (VEGF-A 110, VEGF-A 121, and VEGF-A 189)), VEGF-A 165 neutralization, and HUVEC anti-proliferation. Overall, SB11 exhibits high similarity compared to EU/US-ranibizumab. CONCLUSION: Based on the comprehensive analytical similarity assessment, SB11 is highly similar to the EU/US-ranibizumab with respect to structural, physicochemical, and biological properties.
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spelling pubmed-89275712022-04-01 Evaluation of the Structural, Physicochemical, and Biological Characteristics of SB11, as Lucentis(®) (Ranibizumab) Biosimilar Kim, Eunji Han, Jihyeon Chae, Yunjung Park, Hyerim Kim, Saerom Kim, Seokkyun Lee, Jungmin Kim, Beom Chan Ophthalmol Ther Original Research INTRODUCTION: SB11 was recently approved as a ranibizumab biosimilar by the US Food and Drug Administration (FDA) and the European Commission (EC) as a therapy for retinal vascular disorders under the brand name Byooviz™. This study was performed to assess the analytical similarity between SB11 and reference products from the European Union (EU-ranibizumab) and United States (US-ranibizumab). METHODS: A comprehensive structural, physicochemical, and biological characterization was performed utilizing state-of-the-art analytical methods. Comparisons included the following: primary structure related to amino acid sequence and post-translational modifications; higher order structure; product-related substances and purity/impurity including size and charge variants. In addition, biological characterization included a series of mechanism of action (MoA)-related bioassays such as vascular endothelial growth factor (VEGF)-A binding assay (VEGF-A 165 and its isoforms), cell-based VEGF-A 165 neutralization assay, and anti-proliferation assay using human umbilical vein endothelial cells (HUVEC). RESULTS: The amino acid sequence of SB11 was identical to that of reference products, and post-translational modification profiles and higher order structures of SB11 were shown to be indistinguishable from the reference products. Product-related size and charge variants and aggregates were also similar. Using a broad range of VEGF-related functional assays, we demonstrated that SB11 has similar biological properties to reference products in VEGF-A binding activities (VEGF-A 165 and isoforms (VEGF-A 110, VEGF-A 121, and VEGF-A 189)), VEGF-A 165 neutralization, and HUVEC anti-proliferation. Overall, SB11 exhibits high similarity compared to EU/US-ranibizumab. CONCLUSION: Based on the comprehensive analytical similarity assessment, SB11 is highly similar to the EU/US-ranibizumab with respect to structural, physicochemical, and biological properties. Springer Healthcare 2022-01-27 2022-04 /pmc/articles/PMC8927571/ /pubmed/35084693 http://dx.doi.org/10.1007/s40123-022-00453-7 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Kim, Eunji
Han, Jihyeon
Chae, Yunjung
Park, Hyerim
Kim, Saerom
Kim, Seokkyun
Lee, Jungmin
Kim, Beom Chan
Evaluation of the Structural, Physicochemical, and Biological Characteristics of SB11, as Lucentis(®) (Ranibizumab) Biosimilar
title Evaluation of the Structural, Physicochemical, and Biological Characteristics of SB11, as Lucentis(®) (Ranibizumab) Biosimilar
title_full Evaluation of the Structural, Physicochemical, and Biological Characteristics of SB11, as Lucentis(®) (Ranibizumab) Biosimilar
title_fullStr Evaluation of the Structural, Physicochemical, and Biological Characteristics of SB11, as Lucentis(®) (Ranibizumab) Biosimilar
title_full_unstemmed Evaluation of the Structural, Physicochemical, and Biological Characteristics of SB11, as Lucentis(®) (Ranibizumab) Biosimilar
title_short Evaluation of the Structural, Physicochemical, and Biological Characteristics of SB11, as Lucentis(®) (Ranibizumab) Biosimilar
title_sort evaluation of the structural, physicochemical, and biological characteristics of sb11, as lucentis(®) (ranibizumab) biosimilar
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8927571/
https://www.ncbi.nlm.nih.gov/pubmed/35084693
http://dx.doi.org/10.1007/s40123-022-00453-7
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