Eculizumab
Therapeutic Eculizumab antibody from the original Soliris® commercial drug.
Reference Standard as Aliquots
Soliris®
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Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot
| Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
2022.04 |
Soliris® DE |
4 mg |
Unit: aliquot(s) |
747,00 €
/aliquot
|
Biosimilars as Aliquots
Epysqli®, Bekemv®
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Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot
| Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
tbd; product is not in stock - minimum order quantity applies |
Bekemv® |
3 mg |
410,00 €
/aliquot
|
||||
tbd; product is not in stock - minimum order quantity applies |
Epysqli® |
3 mg |
410,00 €
/aliquot
|
Access Batch Specific Analytical Information
Evidentic’s Analytical Data Service includes a comprehensive array of methods to support the drug development process, including structure, aggregation, degree of isomerization, and N-glycans identification of the active pharmaceutical ingredient (API).
Product Information
Here you will find the product information for the reference product.
Soliris® / Eculizumab Reference Product
| Drug name | Soliris® |
| INN | Eculizumab |
| API type | Eculizumab is a humanised monoclonal (IgG2/4κ) antibody produced in NS0 cell line by recombinant DNA technology. |
| Pharmacotherapeutic group | Selective immunosuppressants |
| ATC code | L04AA25 |
| Target of antibody | C5 complement protein |
| General function | Eculizumab is indicated in adults and children for the treatment of Paroxysmal nocturnal haemoglobinuria (PNH) and Atypical haemolytic uremic syndrome (aHUS). Eculizumab is also indicated in adults for the treatment of Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive, Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Eculizumab is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. Eculizumab preserves the early components of complement activation that are essential for opsonization of microorganisms and clearance of immune complexes. In PNH patients, uncontrolled terminal complement activation and the resulting complement-mediated intravascular haemolysis is blocked with Eculizumab treatment. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | No interaction studies have been performed. Based on the potential inhibitory effect of eculizumab on complement-dependent cytotoxicity of rituximab, eculizumab may reduce the expected pharmacodynamic effects of rituximab. |
| Original license holder | Alexion Europe SAS |
| Marketing authorisation numbers | EU/1/07/393/001 |
| Marketing authorisation holder | Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret FRANCE |
| Name of the manufacturer of the biological active substance | Lonza Biologics Tuas Pte Ltd. 35 Tuas South Avenue 6 Singapore 637377 Lonza Biologics Porriño, S.L. C/ La Relba, s/n. Porriño Pontevedra 36400 Spain Alexion Pharma International Operations Unlimited Company College Business and Technology Park Blanchardstown, Dublin 15 Ireland |
| Name and address of the manufacturer(s) responsible for batch release | Almac Pharma Services 22 Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom Patheon Italia S.p.A Viale G. B. Stucchi, 110 20900 Monza (MB) Italy Alexion Pharma International Operations Unlimited Company College Business and Technology Park Blanchardstown Dublin 15 Ireland |
| Max shelf life | 30 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Sodium phosphate, monobasic Sodium phosphate, dibasic Sodium chloride Polysorbate 80 Water for injections |
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