A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Summary
This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.
Timeline
- Start
- 2018-03-14
- Primary completion
- 2019-05-24
- Completion
- 2019-12-09
Outcome
Met primary endpoint
paper with an adjusted treatment difference of -0.8 letter (90% CI, -1.8 to 0.2 letters). PMID 33211076 ↗
paper with an adjusted treatment difference of -8 μm (95% CI, -19 to 3 μm). PMID 33211076 ↗
paper These findings of equivalent efficacy and similar safety and immunogenicity profiles compared with ranibizumab support the use of SB11 PMID 33211076 ↗
release “위 결과를 통해 삼성바이오에피스가 루센티스 바이오시밀러 개발 임상3상의 1차 유효성 평가 기준을 달성하여 오리지널 의약품과의 임상의학적 동등성을 입증했음을 확인할 수 있다.” samsungbioepis.com ↗
release “임상3상 결과를 통해 오리지널 의약품과 아멜리부주(프로젝트명 SB11)간 효능 및 안전성, 면역원성 등의 동등함을 확인” samil-pharm.com ↗
release “이 차이 및 90% CI가 미리 정의한 동등성 범위인 [-3 letters, 3 letters] 안에 포함되어 기준을 만족함” samil-pharm.com ↗
Publications
- Bressler NM, Kim T, Oh I, Russo P, Kim MY, Woo SJ. Immunogenicity With Ranibizumab Biosimilar SB11 (Byooviz) and Reference Product Lucentis and Association With Efficacy, Safety, and Pharmacokinetics: A Post Hoc Analysis of a Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2023 Feb 1;141(2):117-127. doi: 10.1001/jamaophthalmol.2022.5403.
- Woo SJ, Veith M, Hamouz J, Ernest J, Zalewski D, Studnicka J, Vajas A, Papp A, Gabor V, Luu J, Matuskova V, Yoon YH, Pregun T, Kim T, Shin D, Bressler NM. Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Jan 1;139(1):68-76. doi: 10.1001/jamaophthalmol.2020.5053.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |
| Subject | SB11 | Unknown | 0.5 mg | Intravitreal |