Omalizumab‑Igec

Form: Pre filled syringe

Strength: 75 mg/0.5 mL and 150 mg/mL

Reference Brands: Xolair, Omlyclo - a Biosimilar to Xolair

Category: Biosimilars

Omlyclo, a biosimilar to Xolair (omalizumab), is regulated in the EU and US, supported by dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality compliant with GMP and MDR standards. In the US, FDA approval involves extensive comparability data, clinical validation, and safety assessments. In the EU, CE marking certifies conformity with MDR. These biosimilars undergo validation, stability testing, and audits, with detailed documentation including biosimilarity data, clinical trial results, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and regulatory updates, visit Pharmatradz. Ensuring regulatory compliance guarantees access to affordable, high-quality biosimilar therapies for allergy and asthma management worldwide.