Mogamulizumab
Therapeutic Mogamulizumab antibody from the original Poteligeo® commercial drug.
Reference Standard as Aliquots
Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot
| Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
2023.09 |
Poteligeo® DE |
0.5 mg |
Unit: aliquot(s) |
358,00 €
/aliquot
|
Biosimilars as Aliquots
Access Batch Specific Analytical Information
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Product Information
Here you will find the product information for the reference product.
Poteligeo® / Mogamulizumab Reference Product
| Drug name | Poteligeo® |
| INN | Mogamulizumab |
| API type | Mogamulizumab is produced in Chinese hamster ovary cells by recombinant DNA technology. |
| Pharmacotherapeutic group | Antineoplastic and immunomodulating agents, monoclonal antibodies |
| ATC code | L01FX09 |
| Target of antibody | CCR4, a G protein-coupled receptor for CC chemokines |
| General function | |
| Short description | Mogamulizumab is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy. |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Mogamulizumab is a defucosylated, humanised IgG1 kappa immunoglobulin that selectively binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs including the skin, resulting in depletion of the target cells. CCR4 is expressed on the surface of some cancer cells including T cell malignancies, such as MF and SS in which CCR4 expression is inherent. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | The pharmacokinetics (PK) of Mogamulizumab was evaluated in adult patients with T-cell leukaemia-lymphoma (ATL) and CTCL over a dose range of 0.01 to 1 mg/kg administered as multiple doses of Mogamulizumab every week or every 2 weeks, and included the recommended 1.0 mg/kg dose and regimen. |
| Original license holder | Kyowa Kirin Holdings B.V. Bloemlaan 2 2132NP Hoofddorp Netherlands |
| Marketing authorisation numbers | EU/1/18/1335/001 |
| Marketing authorisation holder | Kyowa Kirin Holdings B.V. Bloemlaan 2 2132NP Hoofddorp Netherlands |
| Name of the manufacturer of the biological active substance | Kyowa Kirin Co., Ltd. Takasaki Plant 100-1 Hagiwara-machi, Takasaki-shi, Gunma, 370-0013 Japan |
| Name and address of the manufacturer(s) responsible for batch release | allphamed PHARBIL Arzneimittel GmbH Hildebrandstr. 10-12 37081 Göttingen Germany |
| Max shelf life | 3 years |
| Storage conditions | 2°C – 8°C |
| List of excipients | Citric acid monohydrate Glycine Polysorbate 80 Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections |
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