- One-year results from the Phase 3 study demonstrated equivalence between SB11 and reference ranibizumab in patients with neovascular age-related macular degeneration
- Marketing Authorization Application (MAA) for SB11 is under review by the European Medicines Agency (EMA)
Samsung Bioepis Co., Ltd. today announced one-year results from the Phase 3 study on SB11, a proposed biosimilar to Lucentis (ranibizumab), in patients with neovascular age-related macular degeneration (nAMD). This data will be presented for the first time at the American Academy of Ophthalmology (AAO) 2020 Virtual, which will be held from November 13 to 15, 2020.
“The 52-week data confirms SB11 has equivalence in efficacy and pharmacokinetics (PK) as well as a comparable safety and immunogenicity profile with the reference product,” said Hee Kyung Kim, Senior Vice President and Clinical Sciences Division and Regulatory Affairs Team Leader at Samsung Bioepis. “The addition of this clinical data reinforces Samsung Bioepis’ ongoing commitment to bringing affordable treatment options to millions of patients with unmet medical needs.”
“As the global prevalence of age-related macular degeneration is increasing with the aging population, there will be a rising demand for anti-VEGF therapies,” said Se Joon Woo, MD, PhD, Professor, Department of Ophthalmology, Seoul National University Bundang Hospital, South Korea. “Biosimilars for anti-VEGF therapies will enable more patients to gain access to treatments and contribute to the prevention of AMD-related blindness.”
A total of 705 patients were enrolled in the Phase 3 study and 634 patients completed the study up to week 52. The study met its primary endpoints, defined as changes from baseline in best corrected visual acuity (BCVA) at week 8 and central subfield thickness (CST) at week 4. Secondary endpoints included long-term efficacy, safety, PK, and immunogenicity, which were comparable between SB11 and reference ranibizumab.
In May 2020, Samsung Bioepis announced 24-week interim results from the Phase 3 study , and the full manuscript on 24-week data is expected to be published in JAMA Ophthalmology in 2020.
The company announced in November 2019 that it has entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the United States (U.S.), Canada, Europe, Japan, and Australia.
SB11 Phase 3 Study
The SB11 Phase 3 study was a randomized, double-masked, multicenter study evaluating the efficacy, safety, PK, and immunogenicity of SB11 compared to reference ranibizumab in patients with nAMD. 705 patients were randomized (1:1) to receive SB11 or reference ranibizumab in monthly injections (0.5 mg), and 634 patients continued to receive treatment up to week 48. Change from baseline in BCVA, CST and other parameters were compared through week 52. Primary endpoints were analyzed by using an analysis of covariance (ANCOVA), and equivalence was declared if the two-sided 90% confidence interval (CI) of the difference of the least squares (LS) mean change from baseline in BCVA at week 8 between two treatments was within the pre-defined margin of ± 3 letters and if the two-sided 95% CI of the difference of the LS mean change from baseline in CST (based on assessment by central reading center) at week 4 between two treatments was within the pre-defined margin of ± 36 μm. Secondary endpoints were long-term efficacy, safety, PK, and immunogenicity.
The LS mean change from baseline in BCVA at week 8 showed an adjusted treatment difference of −0.8 letters (90% CI: −1.8 to 0.2) between SB11 and reference ranibizumab, and the LS mean change from baseline in CST at week 4 showed an adjusted treatment difference of −8 μm (95% CI: −19 to 3) between two products. The LS mean change in BCVA from baseline at week 52 was 9.79 letters for SB11, compared with 10.41 letters for reference ranibizumab (difference: -0.62, [90% CI: -2.092, 0.857]). The LS mean change in CST was −139.55 μm for SB11 vs −124.46 μm for reference ranibizumab (difference: -15.09, [95% CI, -25.617, -4.563]). PK, safety including incidence of treatment-emergent adverse events, and the immunogenicity profile of SB11 and reference ranibizumab were comparable at all timepoints up to week 52.
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 and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, visit www.samsungbioepis.com.
i Lucentis is a registered trademark of Genentech
ii Bressler NM, Woo SJ, et al. Phase III RCT Comparing SB11 (Ranibizumab Biosimilar) with Ranibizumab in Neovascular AMD (nAMD): 1-year Results. American Academy of Ophthalmology 2020. Abstract # 30064285 [Poster on demand #PO393]
iii Samsung Bioepis news release. Available at: https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=169¤tPage=2 [Last accessed October 2020]