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Ranibizumab Biosimilars in Treating Retinal Disorders: A Cost-Effective Revolution?
Chatzimichail, Eleftherios; Pfau, Kristina; Gatzioufas, Zisis; Panos, Georgios D.
Afiliación
  • Chatzimichail E; Department of Ophthalmology, University Hospital of Basel, Basel, Switzerland.
  • Pfau K; Department of Ophthalmology, University Hospital of Basel, Basel, Switzerland.
  • Gatzioufas Z; Department of Ophthalmology, University Hospital Bonn, Bonn, Germany.
  • Panos GD; Department of Ophthalmology, University Hospital of Basel, Basel, Switzerland.
Drug Des Devel Ther ; 18: 365-374, 2024.
Article en En | MEDLINE | ID: mdl-38347957
ABSTRACT
Ranibizumab, is a humanized, monoclonal antibody fragment that binds and inactivates vascular endothelial growth factor-A (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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Edema Macular / Retinopatía Diabética / Degeneración Macular Húmeda / Biosimilares Farmacéuticos Tipo de estudio: Clinical_trials / Health_economic_evaluation Límite: Humans / Newborn Idioma: En Revista: Drug Des Devel Ther Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Suiza Pais de publicación: Nueva Zelanda
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Edema Macular / Retinopatía Diabética / Degeneración Macular Húmeda / Biosimilares Farmacéuticos Tipo de estudio: Clinical_trials / Health_economic_evaluation Límite: Humans / Newborn Idioma: En Revista: Drug Des Devel Ther Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Suiza Pais de publicación: Nueva Zelanda