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

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

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https://pubmed.ncbi.nlm.nih.gov/35084693/

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).


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.