Aflibercept‑Yszy

Form: Injectable solution

Strength: 2 mg/0.05 mL

Reference Brands: Eylea(US & EU); Opuviz biosimilar to biosimilar to Eylea

Category: Biosimilars

Opuviz, a biosimilar of Eylea, is regulated in the EU and US, supported by dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality per GMP standards. In the US, FDA approval involves comprehensive clinical validation, safety assessments, and comparability data. In the EU, CE marking certifies conformity with MDR standards for biosimilars. These products undergo validation, stability testing, and audits, with detailed documentation including safety profiles, clinical data, and manufacturing practices. For licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective ophthalmic biosimilars supporting effective eye disease management worldwide.