Samsung Bioepis announced results from a study analyzing structural and functional similarity between SB11, a proposed ranibizumab biosimilar, and Lucentis (ranibizumab). The study results will be presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2021.
“With biosimilars, it is important to understand ‘totality of the evidence’, a concept which demonstrates how biosimilarity based on structural and functional analysis establishes the basis for equivalent clinical effectiveness and comparable safety with the reference biologic product,” Se Joon Woo, MD, PhD, Professor, Department of Ophthalmology, Seoul National University Bundang Hospital, South Korea, said in a company news release.
Various assays were used to assess structural and functional similarity between SB11 and the reference product:
- Structural and physicochemical characterization: amino acid sequence, post-translational modifications, higher order structure, product-related substances and impurities, and protein concentration
- Biological characterization: vascular endothelial growth factor (VEGF)-A binding assay, cell-based VEGF-A neutralization assay, and human umbilical vein endothelial cells (HUVEC) anti-proliferation assay
The amino acid sequence, post-translational modifications, higher order structure, and size and charge variants of SB11 were similar to that of reference product. SB11 and reference product were also functionally similar based on a set of bioassays and binding assays covering a broad range of VEGF-related functional activities, according to a company news release. (SB11’s binding activity based on VEGF-A binding assay was 98% (RSD=2%); potencies based on HUVEC anti-proliferation and VEGF-A neutralization assay were 101% (RSD=5%) and 99% (RSD=4%), respectively).
“Through this study, we hope more ophthalmologists understand biosimilar development, how extensively the reference biologic is analyzed, and how quality targets are met through structural and functional analysis.” said Donghoon Shin, Vice President and Medical and Lifecycle Safety Team Leader at Samsung Bioepis.
The study is available as e-poster on ARVO website (abstract # 3519210).
The Biologics License Application (BLA) and Marketing Authorization Application (MAA) for SB11 are under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively.