[Source: Samsung Bioepis]
Samsung Bioepis Monday said the results of a post hoc analysis of the Phase 3 study of Samsung Bioepis’ biosimilar SB11 presented during a medical conference in the United States last week further demonstrated the drug’s bioequivalence to blockbuster eye drug Lucentis to raise expectations for sale boost.
SB11, also known as Byooviz, was already approved and launched in the U.S. and other major markets based on the Phase 3 clinical trial that was conducted in 705 patients in nine countries from March 2018 to December 2019.
The results were presented by Neil M. Bressler, a Johns Hopkins University medical professor, who participated in the phase 3 study, at the annual meeting of the American Society of Retina Specialists held on Saturday in New York.
In the trial, equivalence in terms of efficacy was demonstrated for the primary endpoints of change from baseline of best-corrected visual acuity (BCVA) at week 8 and optical coherence tomography central subfield thickness (CST) at week 4.
In this study, statistical analysis was performed to determine whether equivalence was demonstrated even for subgroups with underlying factors that affect the treatment effect and eventually it was confirmed that visual acuity and anatomical measurements were similar between SB11 and its reference drug, Samsung Bioepis said.
This post-hoc analysis further demonstrates the medical equivalence of SB11 to Lucentis, which will help expand the future marketing of SB11 as an optimal alternative for many patients, the company added.
Lucentis developed by Genentech is an ophthalmic disease medication has indications for treating macular degeneration and diabetic macular edema. Lucentis sales were about $3.5 billion last year.
By Kim Si-gyun and Minu Kim
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