Biosimilar Approvals Accelerate Formulary Substitution Pressure
Regulators across the United States, European Union, and increasingly Asian markets are approving anti-VEGF biosimilars at an accelerating pace, creating formulary substitution pressure that branded originators have not faced since intravitreal anti-VEGF therapy became the standard of care for retinal vein occlusion. Approval has required biosimilar manufacturers to complete extensive comparative efficacy trials, a process that can take three to five years per agent given rigorous regulatory bioequivalence requirements across different jurisdictions. Manufacturers with established biosimilar manufacturing capability and approved agents are capturing share from originator brands unable to defend list pricing against lower-cost formulary alternatives.
Market Impact: Adds 4 percent volume from aging








