Obinutuzumab

Therapeutic Obinutuzumab antibody from the original Gazyvaro® commercial drug

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CD20
Monoclonal Antibody
Gazyvaro®
25 mg/mL
240 µL
6 mg
-80°C
06/2019
442,00 
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CD20
Monoclonal Antibody
Gazyvaro®
25 mg/mL
240 µL
6 mg
-80°C
08/2019
442,00 
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Max: 10
Min: 1
Step: 1

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Gazyvaro® / Obinutuzumab Reference Product

Drug nameGazyvaro®
INNObinutuzumab
API typeObinutuzumab is a Type II humanised anti-CD20 monoclonal antibody of the IgG1 subclass derived by humanisation of the parental B-Ly1 mouse antibody and produced in the Chinese Hamster Ovary cell line by recombinant DNA technology
Pharmacotherapeutic group
Antineoplastic agents, monoclonal antibodies
ATC code
L01XC15
Target of antibody
CD20; Synonyms: B1, Bp35,  CVID5, LEU-16, MS4A2, S7, AA960661, Cd20, Ly-44, Ms4a2, MS4A1, bp35, cd20, ms4a2, leu-16, ms4a4c, cd20-like
General function
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Obinutuzumab is a recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype. It specifically targets the extracellular loop of the CD20 transmembrane
antigen on the surface of non-malignant and malignant pre-B and mature B-lymphocytes, but not on haematopoietic stem cells, pro-B-cells, normal plasma cells or other normal tissue. Glycoengineering of the Fc part of obinutuzumab results in higher affinity for FcɣRIII receptors on immune effector cells such as natural killer (NK) cells, macrophages and monocytes as compared to nonglycoengineered antibodies.
In nonclinical studies, obinutuzumab induces direct cell death and mediates antibody dependent cellular cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP) through recruitment of FcɣRIII positive immune effector cells. In addition, in vivo, obinutuzumab mediates a low degree of complement dependent cytotoxicity (CDC). Compared to Type I antibodies, obinutuzumab, a Type II antibody, is characterised by an enhanced direct cell death induction with a concomitant reduction in CDC at an equivalent dose. Obinutuzumab, as a glycoengineered antibody, is characterised by enhanced antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP) compared to non-glycoengineered antibodies at an equivalent dose. In animal models obinutuzumab mediates potent B-cell depletion and antitumour efficacy.
In the pivotal clinical study BO21004/CLL11, 91% (40 out of 44) of evaluable patients treated with Gazyvaro were B-cell depleted (defined as CD19+ B cell counts < 0.07 x 109/L) at the end of treatment period and remained depleted during the first 6 months of follow up. Recovery of B-cells was observed within 12-18 months of follow up in 35% (14 out of 40) of patients without progressive disease and 13% (5 out of 40) with progressive disease.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)
Original license holder
Marketing authorisation numbers
EU/1/14/937/001
Marketing authorisation holder
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Name of the manufacturer of the biological active substance
Roche Diagnostics GmbH
Nonnenwald 2
82377 Penzberg
Germany
Name and address of the manufacturer(s) responsible for batch releaseRoche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Max shelf life
36 months
Storage conditions
2°C – 8°C
List of excipients
L-histidine
L-histidine hydrochloride monohydrate
Trehalose dihydrate
Poloxamer 188
Water for injections
Evidentic Support
+49 (0) 30 959 99 8831

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