Omalizumab‑Igec 75 mg/0.5 mL and 150 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Pre filled syringe

Available Strengths: 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), blocks immunoglobulin E (IgE), reducing allergic reactions and inflammation. It effectively treats asthma, chronic idiopathic urticaria, and other allergies. Benefits include similar efficacy, lower costs, increased access, and improved allergy management when used under medical supervision.

Product Description:

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.