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 r...
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Published in | Ophthalmology and therapy Vol. 11; no. 2; pp. 639 - 652 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Cheshire
Springer Healthcare
01.04.2022
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Subjects | |
Online Access | Get full text |
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Summary: | 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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Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
ISSN: | 2193-8245 2193-6528 |
DOI: | 10.1007/s40123-022-00453-7 |