Aflibercept‑Ayyh

Form: Intravitreal injection (liquid solution)

Strength: 2 mg/0.05 mL

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

Category: Biosimilars

Pavblu, a biosimilar of Eylea (aflibercept), is regulated in the EU and US with dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality in compliance with GMP standards. In the US, FDA approval involves 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 data, and manufacturing practices. For licensing procedures, approved dossiers, and regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to affordable, high-quality ophthalmic biosimilars supporting effective treatment of eye diseases worldwide.