Therapeutic Bevacizumab antibody from the original Avastin® commercial drug

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Avastin® / Bevacizumab Reference Product

Drug nameAvastin®
API typeBevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
Pharmacotherapeutic group
Antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies
ATC code
L01X C07
Target of antibody
VEGF-A; Synonyms: vegf, vegfa, wu:fj82c06, VEGF, vegf-a, vpf, vefg, VPF, eVEGF120, eVEGF164, MVCD1, Vegf, Vegf120, Vegf164, Vegf188, Vpf, VEGF164
General functioninhibits vascular endothelial growth factor A and is commonly used to treat various cancers, including colorectal, lung, breast, kidney, and glioblastomas
Short descriptionBevacizumab is comprised of a tetramer of two heavy and two light chains with one N-glycosylation site per heavy chain Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis
and angiogenesis, and thereby inhibits the binding of VEGF to its receptors, Flt-1 (VEGFR-1) and
KDR (VEGFR-2), on the surface of endothelial cells. Neutralising the biological activity of VEGF
regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the
formation of new tumour vasculature, thereby inhibiting tumour growth.
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Administration of bevacizumab or its parental murine antibody to xenotransplant models of cancer in
nude mice resulted in extensive anti-tumour activity in human cancers, including colon, breast,
pancreas and prostate. Metastatic disease progression was inhibited and microvascular permeability
was reduced.
MBC and EBC patients had similar PK parameters (e.g. clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC). Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for AGC. The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 μg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC, and AGC patients. The central compartment volume was 2.62 L for patients with MBC and EBC and 3.63 L for patients with AGC.
In the final population PK model, in addition to primary tumor type, body-weight, serum aspartate aminotransferase and albumin were identified as a statistically significant covariates affecting the exposure of trastuzumab. However, the magnitude of effect of these covariates on trastuzumab exposure suggests that these covariates.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)n/a
Original license holder
Marketing authorisation numbers
EU/1/04/300/001 - 002
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
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990

Genentech, Inc.
1 Antibody Way
Oceanside, CA 92056
F. Hoffmann-La Roche Ltd
Grenzacherstrasse 124
CH-4070 Basel

Roche Singapore Technical Operations, Pte. Ltd.
10 Tuas Bay Link
Singapore 637394
Name and address of the manufacturer(s) responsible for batch releaseRoche Pharma AG
Emil-Barrell-Str. 1,
D-79639 Grenzach-Wyhlen
Max shelf life
24 months
Storage conditions
2°C – 8°C
List of excipients
Trehalose dihydrate
Sodium phosphate
Polysorbate 20
Water for injections
Evidentic Support
+49 (0) 30 959 99 8831

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