Samsung Bioepis Presents 52 Weeks P-III Study Results of SB15, Proposed biosimilar to Eylea (aflibercept) for Neovascular Age-Related Macular Degeneration at ARVO 2023
Shots:
- The company highlighted the 1yr. results from the P-III study evaluating SB15 vs aflibercept. Additionally, 32wk. interim results from the same study were previously presented at AAO 2022
- SB15 showed comparable efficacy, safety, immunogenicity & PK profiles to reference aflibercept @~56wks. along with improvements in BCVA & anatomic outcomes. Switching from aflibercept to SB15 did not reveal any treatment-emergent issues i.e., loss of efficacy, increased AEs or immunogenicity,
- New analytical data on similarity b/w SB15 and the reference product were also presented where SB15 showed high similarity to AFL with respect to structural, physicochemical, and biological properties
Ref: Samsung Bioepis | Image: Samsung Bioepis
Related News:- Samsung Bioepis Reports P-I Study Results of SB17, a Proposed Biosimilar to Stelara
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