Aflibercept-Mrbb

Form: Intravitreal injection (liquid solution)

Strength: 2mg (0.05 mL of a 40 mg/mL solution)

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

Category: Biosimilars

Ahzantive, a biosimilar of Eylea, is regulated in the EU and US, supported by dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality in compliance with GMP and MDR standards. In the US, FDA approval involves extensive 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 results, and manufacturing practices. For licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to affordable, effective ophthalmic biosimilars supporting eye disease management worldwide.