Omalizumab 150mg (biosimilar)
Product Overview
| Generic Name | Omalizumab 150mg (biosimilar) |
| Brand Name(s) | Xolair; Omlyclo |
| Category | Antibodies, monoclonal |
| Form | polvo liofilizado |
| Strength | 150 mg por vial |
| Therapeutic Class | Anti-IgE para asma alérgica, urticaria crónica espontánea, pólipos nasales y alergia alimentaria |
| ATC Code | R03DX05 |
Manufacturing & Regulatory
| Manufacturer | Novartis Europharm Limited, Celltrion |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Type II |
| COFEPRIS | 010.000.7005.00 |
| Free Sale Certificate | may obtain export certificate from regulatory authority |
Logistics & Export
| MOQ | 10 Vials |
| Shelf Life | 48 Months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Supplied per batch upon request |
| SDS-Safety Data Sheet (PDF) | Manufacturer provides standard SDS (biologic/aqueous injectable) |
| CTD Summary (PDF) | CTD available to regulators; summary available to qualified partners |
Special Notes
Omalizumab es un anticuerpo anti-IgE subcutáneo. Indicaciones: asma alérgica moderada-grave, urticaria crónica espontánea (UCE/CIU), rinosinusitis crónica con pólipos nasales (CRSwNP), alergia alimentaria mediada por IgE (≥1 año) como coadyuvante a la evitación estricta