On 20 August 2026 the FDA approved a supplement to BLA 761274 - YESAFILI, Biocon Biologics' aflibercept-jbvf, a biosimilar to aflibercept. A supplemental approval modifies a licence that already exists; it can cover manufacturing, presentation, labelling or an added population, and the approval record names the application and sponsor without stating which.
So the substantive change, if any, has to be read from the current prescribing information rather than inferred from the listing. What the approval does not do is alter the clinical position of aflibercept or of biosimilars to it.
The reason this is worth a paragraph is the supply question rather than the science. Anti-VEGF therapy is the single largest recurring cost in most retina services, and biosimilar aflibercept is the mechanism by which that cost falls. Biocon is an Indian manufacturer, so the regulatory progress of this product in the United States is a reasonable leading indicator of what becomes available and affordable elsewhere - though what is licensed by CDSCO is a separate question that this approval does not answer. For a clinician the practical points are the ones that apply to any biosimilar switch: record the specific product and batch given, and treat interchangeability as a regulatory determination rather than an assumption.
- Read this as a supplement to an existing biosimilar licence, not a new approval.
- Record the specific product name and batch for every intravitreal injection, not just 'aflibercept'.
- Treat interchangeability as a regulatory status to be checked, not assumed from biosimilarity.
- This is an FDA action; CDSCO status and Indian availability are separate questions it does not address.
- Where a service switches product, plan the pharmacovigilance - a change in presentation is a change in the injection workflow.
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