Bevacizumab

Therapeutic Bevacizumab antibody from the original Avastin® commercial drug.

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Product Batch	Antigen	Molecular Class	Drug Brand	Product Concentration	CoA	Quantity per vial	Storage Temperature	Expiry Date	Price from
Bevacizumab	VEGF-A	Monoclonal Antibody	Zirabev®	25 mg/mL	–	2 mg	tba	tba	200,00 €	view product Max: Min: 11 Step: 1
Bevacizumab	VEGF-A	Monoclonal Antibody	Oyavas®	25 mg/mL	–	2 mg	tba	tba	197,00 €	view product Max: Min: 11 Step: 1
Bevacizumab	VEGF-A	Monoclonal Antibody	Alymsys®	25 mg/mL	–	2 mg	tba	tba	197,00 €	view product Max: Min: 11 Step: 1
Bevacizumab	VEGF-A	Monoclonal Antibody	Aybintio®	25 mg/mL	–	2 mg	tba	tba	197,00 €	view product Max: Min: 11 Step: 1
Bevacizumab	VEGF-A	Monoclonal Antibody	Abevmy®	25 mg/mL	–	2 mg	tba	tba	207,00 €	view product Max: Min: 11 Step: 1
Bevacizumab	VEGF-A	Monoclonal Antibody	Vegzelma®	25 mg/mL	–	2 mg	tba	tba	198,00 €	view product Max: Min: 11 Step: 1
Bevacizumab B7219H04	VEGF-A	Monoclonal Antibody	Avastin®	25 mg/mL	–	2 mg	-80°C	2018.06	212,00 €	view product Max: 10 Min: 2 Step: 1
Bevacizumab B7223H06	VEGF-A	Monoclonal Antibody	Avastin®	25 mg/mL	–	2 mg	-80°C	2018.09	212,00 €	view product Max: 10 Min: 2 Step: 1
Bevacizumab B7223H17	VEGF-A	Monoclonal Antibody	Avastin®	25 mg/mL	–	2 mg	-80°C	2018.09	212,00 €	view product Max: 10 Min: 2 Step: 1
Bevacizumab B7226H07	VEGF-A	Monoclonal Antibody	Avastin®	25 mg/mL	–	2 mg	-80°C	2018.12	212,00 €	view product Max: 10 Min: 2 Step: 1
Bevacizumab B7230H14	VEGF-A	Monoclonal Antibody	Avastin®	25 mg/mL	–	2 mg	-80°C	2019.03	212,00 €	view product Max: 10 Min: 2 Step: 1
Bevacizumab B7234H02	VEGF-A	Monoclonal Antibody	Avastin®	25 mg/mL	–	2 mg	-80°C	2019.08	212,00 €	view product Max: 10 Min: 2 Step: 1
Bevacizumab B8020H05	VEGF-A	Monoclonal Antibody	Avastin®	25 mg/mL	–	2 mg	-80°C	2019.10	212,00 €	view product Max: 10 Min: 2 Step: 1
Bevacizumab B8800H28	VEGF-A	Monoclonal Antibody	Avastin®	25 mg/mL	yes	2 mg	-80°C	2021.03	212,00 €	view product Max: 6 Min: 2 Step: 1
Bevacizumab H0152B21	VEGF-A	Monoclonal Antibody	Avastin®	25 mg/mL	–	3 mg	-80°C	2017.09	267,00 €	view product Max: 10 Min: 2 Step: 1
Bevacizumab H0156B21	VEGF-A	Monoclonal Antibody	Avastin®	25 mg/mL	–	3 mg	-80°C	2018.03	267,00 €	view product Max: 10 Min: 2 Step: 1
Bevacizumab H0340H03	VEGF-A	Monoclonal Antibody	Avastin®	25 mg/mL	yes	2 mg	-80°C	2024.07	212,00 €	view product Max: 10 Min: 2 Step: 1
Bevacizumab H0403H07	VEGF-A	Monoclonal Antibody	Avastin®	25 mg/mL	–	2 mg	-80°C	2027.03	212,00 €	view product Max: 10 Min: 2 Step: 1

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Avastin^® / Bevacizumab Reference Product

Drug name	Avastin®
INN	Bevacizumab
API type	Bevacizumab 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 function	Inhibits vascular endothelial growth factor A and is commonly used to treat various cancers, including colorectal, lung, breast, kidney, and glioblastomas
Short description	Bevacizumab 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 USA Genentech, Inc. 1 Antibody Way Oceanside, CA 92056 USA F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 CH-4070 Basel Switzerland Roche Singapore Technical Operations, Pte. Ltd. 10 Tuas Bay Link Singapore 637394 Singapore
Name and address of the manufacturer(s) responsible for batch release	Roche Pharma AG Emil-Barrell-Str. 1, D-79639 Grenzach-Wyhlen Germany
Max shelf life	24 months
Storage conditions	2°C – 8°C
List of excipients	Trehalose dihydrate Sodium phosphate Polysorbate 20 Water for injections