Biosimilars of anti-VEGF agents in retinal diseases: a narrative review of regulatory, clinical, and pharmacoeconomic aspects - PubMed
3 hours ago
- #Biosimilars
- #Anti-VEGF Agents
- #Retinal Diseases
- Biosimilars of anti-VEGF agents are cost-effective alternatives for retinal diseases like neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion, following patent expirations of originator drugs like ranibizumab and aflibercept.
- Regulatory frameworks (FDA, EMA, NMPA) ensure biosimilarity through rigorous analytical characterization, preclinical evaluation, and clinical trials, with Phase III studies confirming therapeutic equivalence in visual acuity, safety, and immunogenicity for approved biosimilars such as ranibizumab-nuna and aflibercept-abzv.
- Real-world evidence supports comparable outcomes for ranibizumab biosimilars, while data for aflibercept biosimilars remain preliminary and require ongoing pharmacovigilance; pharmacoeconomic analyses show 20-40% cost reductions, improving healthcare savings and patient access.
- Implementation considerations include understanding extrapolation principles, switching protocols, and clinic workflow integration, with future research needed on long-term outcomes, broader implementation studies, and pharmacovigilance monitoring to guide evidence-based adoption in clinical practice.