[Fédération France Macula Practical Guidelines for the Use of Anti-VEGF Biosimilars].

PURPOSE: The introduction of biosimilars for anti-vascular endothelial growth factor (anti-VEGF) represents a challenging shift in the management of retinal diseases requiring long-term intravitreal therapy. While regulatory approval has been supported by robust biosimilarity programs, important practical questions remain regarding treatment initiation, switching strategies, pharmacovigilance, patient acceptance, and integration into routine clinical practice.

METHODS

A narrative review of the literature was conducted using the available evidence on anti-VEGF biosimilars, including pivotal phase III clinical trials, real-world studies, recommendations from European and French regulatory agencies, and recent legislative developments. Practical recommendations were developed by a panel of experts from the Fédération France Macula based on a critical appraisal of the available evidence and an expert consensus, which was formalized during a dedicated expert roundtable held at the MaculArt 2026 congress.

RESULTS

Available evidence supports the clinical equivalence of ranibizumab and aflibercept biosimilars compared with their reference products regarding visual outcomes, anatomical efficacy, safety, and immunogenicity. Biosimilars may therefore be considered appropriate therapeutic alternatives in approved retinal indications. The expert panel recommends that treatment decisions remain individualized and driven primarily by clinical considerations. Initiation of therapy with a biosimilar may be considered in selected clinical situations, while switching from a reference product to a biosimilar can be performed in clinically stable patients under appropriate monitoring. Comprehensive traceability and pharmacovigilance remain essential components of patient management. Given the limited evidence currently available, repeated switching between multiple biosimilars or between biosimilars and reference products should be approached with caution.

CONCLUSION

Anti-VEGF biosimilars are expected to play an increasingly important role in retinal care by expanding treatment accessibility and contributing to healthcare sustainability. Their successful implementation requires a thorough understanding of regulatory requirements, careful patient selection, and continued post-marketing surveillance. These recommendations provide a practical framework for the integration of biosimilars into contemporary retinal practice.