Samsung Bioepis "Lucentis Biosimilar 'SB11' Demonstrates Equivalence in Post-Analysis"

US Retina Society Reveals Follow-up Results of Phase 3 Clinical Trial
Launching in Korea, US, and Europe Markets... US Release in June

Samsung Bioepis Lucentis Biosimilar 'SB11' (sold as 'Byooviz' in the US and Europe)

[Asia Economy Reporter Lee Gwan-joo] Samsung Bioepis announced on the 18th that it presented research results on the Lucentis biosimilar 'SB11' (generic name ranibizumab) at the American Society of Retina Specialists (ASRS) conference held in New York from the 13th to the 16th (local time).

Samsung Bioepis disclosed a post-analysis of Phase 3 clinical data for patients with macular degeneration. In the Phase 3 clinical trial conducted on 705 patients across 9 countries, medical equivalence with the original drug was demonstrated through a comparative study based on prescription data from 634 patients who completed the 52-week trial.

The primary endpoints set by Samsung Bioepis for the clinical trial were the change in best corrected visual acuity (BCVA) at week 8 (improvement in vision) and the change in central subfield thickness (CST) at week 4 (reduction in thickness).

This study conducted statistical analysis to verify whether equivalence was maintained when analyzing subgroups considering baseline factors affecting treatment efficacy from the clinical trial data. The results confirmed that vision and anatomical measurement values were similar between SB11 and the original drug.

A Samsung Bioepis official stated, “Through the post-analysis of SB11 Phase 3 clinical data, we were able to further demonstrate medical equivalence compared to the original drug,” adding, “We will focus on expanding sales so that SB11 can be an optimal treatment alternative for many patients.”

The original drug of SB11, Lucentis, developed by Genentech, is an ophthalmic treatment for wet (neovascular) age-related macular degeneration and diabetic macular edema, with annual product sales reaching approximately 4.4 trillion KRW last year.

Samsung Bioepis obtained the first approval to sell the Lucentis biosimilar under the trade name 'Byooviz' in Europe and the United States in August and September last year, respectively, and under the trade name 'Amelibu' in Korea in May this year. Last month, the product was launched in the U.S. market by partner Biogen at a price about 40% lower than the original drug, and domestically, Samsung Bioepis signed a marketing partnership with Samil Pharmaceutical in preparation for market entry.

This content was produced with the assistance of AI translation services.