Aflibercept‑Jbvf

Form: Intravitreal injection (liquid solution)

Strength: 2 mg/0.05 mL per injection

Reference Brands: Eylea; Yesafili- biosimilar of Eylea

Category: Biosimilars

Yesafili, a biosimilar of Eylea (aflibercept), is regulated in the EU and US, supported by dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality according to GMP standards. In the US, FDA approval requires extensive comparability data, validation, and clinical validation. In the EU, CE marking certifies conformity under MDR standards. These biosimilars undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical trial results, and manufacturing practices. For licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to affordable, high-quality ophthalmic biosimilars for eye disease management worldwide.