Ranibizumab Biosimilars in Treating Retinal Disorders: A Cost-Effective Revolution?

被引:4
作者
Chatzimichail, Eleftherios [1 ]
Pfau, Kristina [1 ,2 ]
Gatzioufas, Zisis [1 ]
Panos, Georgios [3 ,4 ,5 ]
机构
[1] Univ Hosp Basel, Dept Ophthalmol, Basel, Switzerland
[2] Univ Hosp Bonn, Dept Ophthalmol, Bonn, Germany
[3] Nottingham Univ Hosp, Queens Med Ctr, Dept Ophthalmol, Nottingham, England
[4] Univ Nottingham, Sch Med, Div Ophthalmol & Visual Sci, Nottingham, England
[5] Queens Med Ctr, Dept Ophthalmol, Derby Rd, Nottingham NG7 2UH, England
关键词
ranibizumab; biosimilars; age-related macular degeneration; diabetic macular edema; retinal disorders; retinal vein occlusion; cost-effectiveness; MACULAR DEGENERATION; EFFICACY; BINDING; SAFETY; BURDEN;
D O I
10.2147/DDDT.S457303
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
: Ranibizumab, is a humanized, monoclonal antibody fragment that binds and inactivates vascular endothelial growth factorA (VEGF-A) and VEGF-B. One of the main indications for an intravitreal treatment with ranibizumab is age-related macular degeneration (AMD), which is a retinal disease with a high worldwide socioeconomic impact. Biosimilars constitute biological products that demonstrate similar pharmacodynamic and pharmacokinetic characteristics with a reference product, as well as comparable clinical efficacy, safety and immunogenicity. Since the approval of the first biosimilar Razumab, there has been a variety of new biosimilars available on the market. They offer the advantage of the same good clinical and safety results at a better price. All Ranibizumab biosimilars that have gained approval were tested in double masked Phase 3 clinical studies. The use of Ranibizumab biosimilars in neovascular AMD is well reported in the bibliography. Nevertheless, over the last few years, there is a tendency of using biosimilars in other retinal diseases like retinopathy of prematurity (ROP), diabetic macular edema (DME) or polypoidal choroidal vasculopathy (PCV). In conclusion, ranibizumab biosimilars offer a promising avenue for the management of retinal diseases, especially in countries with lower socioeconomic status, where there is lack of availability of innovator ranibizumab. However, further research is required to fully explore their efficacy, safety, and long-term outcomes in a plethora of retinal diseases.
引用
收藏
页码:365 / 374
页数:10
相关论文
共 39 条
[11]   Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration [J].
Holz, Frank G. ;
Oleksy, Piotr ;
Ricci, Federico ;
Kaiser, Peter K. ;
Kiefer, Joachim ;
Schmitz-Valckenberg, Steffen .
OPHTHALMOLOGY, 2022, 129 (01) :54-64
[12]   From Biologics to Biosimilars and Biobetters - Democratization of High-end Therapeutics [J].
Honavar, Santosh G. .
INDIAN JOURNAL OF OPHTHALMOLOGY, 2021, 69 (02) :207-208
[13]   Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction [J].
Ingrasciotta, Ylenia ;
Cutroneo, Paola M. ;
Marciano, Ilaria ;
Giezen, Thijs ;
Atzeni, Fabiola ;
Trifiro, Gianluca .
DRUG SAFETY, 2018, 41 (11) :1013-1022
[14]   Impact of out-of-pocket costs on patient initiation, adherence and persistence rates for patients treated with anti-vascular endothelial growth factor medicines [J].
Jackson, Shaun ;
Stokes, John P. .
CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY, 2020, 48 (04) :477-485
[15]   ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR BIOSIMILARS IN OPHTHALMOLOGY [J].
Kaiser, Peter K. K. ;
Schmitz-Valckenberg, Marc Steffen ;
Holz, Frank G. G. .
RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES, 2022, 42 (12) :2243-2250
[16]   Biosimilars: Key regulatory considerations and similarity assessment tools [J].
Kirchhoff, Carol F. ;
Wang, Xiao-Zhuo Michelle ;
Conlon, Hugh D. ;
Anderson, Scott ;
Ryan, Anne M. ;
Bose, Arindam .
BIOTECHNOLOGY AND BIOENGINEERING, 2017, 114 (12) :2696-2705
[17]   Comparison of bevacizumab, ranibizumab, and pegaptanib in vitro: Efficiency and possible additional pathways [J].
Klettner, Alexa ;
Roider, Johann .
INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, 2008, 49 (10) :4523-4527
[18]   Randomized Trial of Biosimilar XSB-001 versus Reference Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration [J].
Loewenstein, Anat ;
Czumbel, Norbert ;
Ernest, Jan ;
Dusova, Jaroslava ;
Pearlman, Joel ;
Nowosielska, Agnieszka .
OPHTHALMOLOGY RETINA, 2023, 7 (09) :753-761
[19]   Molecular Motifs in Vascular Morphogenesis: Vascular Endothelial Growth Factor A (VEGFA) as the Leading Promoter of Angiogenesis [J].
Lungu, Claudiu N. ;
Mehedinti, Mihaela C. .
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES, 2023, 24 (15)
[20]   Oxygen sensing and metabolic homeostasis [J].
Palmer, Biff F. ;
Clegg, Deborah J. .
MOLECULAR AND CELLULAR ENDOCRINOLOGY, 2014, 397 (1-2) :51-58