Analytical Characterization for Similarity Assessment Between an Aflibercept Biosimilar SB15 and Reference Product (Eylea).

Introduction: SB15 is a proposed biosimilar product of reference aflibercept (Eylea), an approved biological drug product for retinal diseases including neovascular age-related macular degeneration (nAMD). This study aimed to assess the analytical similarity between SB15 and its commercially available reference product (RP) sourced from the United States (US-aflibercept) and European Union (EU-aflibercept) in terms of structural, physicochemical, and biological properties.

Methods: A panel of state-of-the-art analytical methods was used for the comprehensive characterization of SB15 and US/EU-aflibercept.

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 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.

Antibody neutralization of cell-surface gC1qR/HABP1/SF2-p32 prevents lamellipodia formation and tumorigenesis.

We previously demonstrated that cell-surface gC1qR is a key regulator of lamellipodia formation and cancer metastasis. Here, we screened a monoclonal mouse antibody against gC1qR to prevent cell migration by neutralizing cell-surface gC1qR. The anti-gC1qR antibody prevented growth factor-stimulated lamellipodia formation, cell migration and focal adhesion kinase activation by inactivating receptor tyrosine kinases (RTKs) in various cancer cells such as A549, MDA-MB-231, MCF7 and HeLa cells.