• The post-hoc analysis shows that baseline age, best corrected visual acuity (BCVA), central subfield thickness (CST), and total lesion size were identified to be associated with the visual acuity and anatomical outcomes when managing neovascular age-related macular degeneration (nAMD) with BYOOVIZ™ or reference ranibizumab, LUCENTIS®i
• The subgroup analysis, based on associated baseline factors was conducted on week 52 change from baseline for BCVA outcomes, shows the similarity in the change from baseline in BCVA between BYOOVIZ™ and reference ranibizumab in each subgroup supporting equivalent clinical efficacy between the products
• These analysis results to be presented at EURETINA 2021 which further reinforce confidence in biosimilarity between BYOOVIZ™ and the reference ranibizumab
INCHEON, Korea – September 09, 2021 – Samsung Bioepis Co., Ltd. today announced results from a post-hoc and subgroup analysis of Phase 3 clinical study of BYOOVIZ™ (ranibizumab biosimilar) identifying the baseline factors associated with visual acuity and anatomical outcomes at both primary endpoints through week 52. The study results will be presented at the EURETINA 2021 Virtual Congress as an e-poster with voice recording.
“This post-hoc analysis of a Phase 3 study presented at EURETINA 2021 demonstrates important baseline factors that determine efficacy outcomes of nAMD treatment,” said Donghoon Shin, Vice President and Medical and Lifecycle Safety Team Leader at Samsung Bioepis. “Additional subgroup analysis showed that there was no difference between BYOOVIZ and the reference ranibizumab in week 52 visual outcomes in many different subgroups, and this result further supports biosimilarity between BYOOVIZ and reference ranibizumab. This goes to show that BYOOVIZ is an effective and a valuable treatment option for nAMD patients worldwide”.
In the study, a total of 634 patients whose median (min, max) age was 75 (51, 96) years, were randomized to receive monthly 0.05 mL intravitreal injections of either 0.5 mg BYOOVIZ™ or 0.5 mg reference ranibizumab. The primary endpoints were change from baseline in best corrected visual acuity (BCVA) at week 8 and change in central subfield thickness (CST) at week 4 with both endpoints then followed through week 52. Associations between baseline factors and treatment responses of BCVA and CST at week 52 were assessed by linear regression analyses, then multivariable analysis on baseline factors that were identified to have a pre-specified P value of <0.001.
Additionally, a subgroup analysis based on associated baseline factors was conducted on week 52 change from baseline for BCVA outcomes. The study demonstrated that the baseline age, BCVA, CST, and total lesion size were identified to be associated with visual acuity and anatomical outcomes when managing nAMD with BYOOVIZ™ or reference ranibizumab. The similar visual outcomes of the two products in the change from baseline in BCVA in many different subgroups further support the equivalent clinical efficacy.
The details of the study are available on EURETINA 2021 virtual website here.
BYOOVIZ™ has been approved by the European Commission as of August 2021, and will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen including BENEPALI™, IMRALDI™ and FLIXABI™ which achieved anti-TNF market leadership in the combined pharmaceutical market in Europe.
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BYOOVIZ™ Post-hoc and Subgroup Analysis
To provide additional confidence regarding the equivalency of BYOOVIZ™ (SB11), the results of a post-hoc analysis was undertaken to identify baseline factors associated with visual acuity and anatomical outcomes in BYOOVIZ™ vs rRBZ (reference ranibizumab), specifically optical coherence tomography (OCT) central subfield thickness (CST) at week 52, as well as a subgroup analysis based on baseline factors judged relevant. A total of 634 patients participated in a randomized, double-masked, parallel-group, multicenter, 52-week phase 3 clinical trial(SB11: n=307; rRBZ: n=327), whose median (min, max) age was 75 (51, 96) years.
From a post-hoc regression analysis, baseline age, best corrected visual acuity (BCVA) and total lesion size were associated with mean change from baseline improvement in BCVA at week 52. Similarly, baseline age, BCVA and CST were associated with reduction in mean change from baseline CST at week 52. For every year of participant age, the mean change from baseline BCVA improvement was reduced by 0.19 letters (95% CI, -0.29 to -0.08; P<0.001) and CST showed additional thickness reduction by 1.26 μm (95% CI, -1.87 to -0.66; P<0.001). For every 1 letter increment of BCVA at baseline, the mean BCVA improvement was reduced by 0.22 letters (95% CI, -0.31 to -0.14; P <.001). For every 1 μm increment of baseline CST, CST showed additional thickness reduction by 0.71 μm (95% CI, -0.76 to -0.66; P<0.001). Overall, the subgroup analysis of change from baseline in BCVA by associated baseline factors showed comparable treatment effects within each subgroup between BYOOVIZ™ and rRBZ across important baseline characteristics, supporting the robustness of the previously reported primary and secondary outcomes.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology, and gastroenterology. For more information, please visit: www.samsungbioepis.com
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