Trastuzumab
Therapeutic Trastuzumab antibody from the original Herceptin® and biosimilar commercial drugs.
Reference Standard as Aliquots
Herceptin®
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Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot
| Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
2028.11 |
Herceptin® DE |
2 mg |
Unit: aliquot(s) |
144,00 €/aliquot
|
|||
2020.08 |
Herceptin® LV |
2 mg |
Unit: aliquot(s) |
169,00 €
/aliquot
|
|||
2021.02 |
Herceptin® DE |
2 mg |
Unit: aliquot(s) |
169,00 €
/aliquot
|
|||
2021.08 |
Herceptin® DE |
2 mg |
Unit: aliquot(s) |
169,00 €
/aliquot
|
|||
2026.12 |
Herceptin® DE |
2 mg |
Unit: aliquot(s) |
144,00 €/aliquot
|
|||
2019.11 |
Herceptin® LV |
2 mg |
Unit: aliquot(s) |
169,00 €
/aliquot
|
|||
2020.12 |
Herceptin® DE |
2 mg |
Unit: aliquot(s) |
169,00 €
/aliquot
|
Biosimilars as Aliquots
Herzuma®, Ontruzant®, Kanjinti®, Zercepac®, Ogivri®
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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 |
Herzuma® DE |
6 mg |
367,00 €
/aliquot
|
||||
tbd; product is not in stock - minimum order quantity applies |
Ontruzant® |
2 mg |
164,00 €
/aliquot
|
||||
2025.01 |
Kanjinti® DE |
6 mg |
Unit: aliquot(s) |
367,00 €
/aliquot
|
|||
2026.08 |
Zercepac® DE |
6 mg |
Unit: aliquot(s) |
275,00 €/aliquot
|
|||
2025.10 |
Ogivri® DE |
6 mg |
Unit: aliquot(s) |
451,00 €
/aliquot
|
|||
2026.09 |
Trazimera® DE |
2 mg |
Unit: aliquot(s) |
123,00 €/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.
Herceptin® / Trastuzumab Reference Product
| Drug name | Herceptin® |
|---|---|
| INN | Trastuzumab |
| API type | One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures |
| Pharmacotherapeutic group | Antineoplastic agents, monoclonal antibodies |
| ATC code | L01XC03 |
| Target of antibody | HER2; Synonyms: CD340, HER-2, HER-2/neu, MLN 19, NEU, NGL, TKR1, Erbb-2, Neu, c-erbB2, c-neu, mKIAA3023, wu:fv70f10, zgc:63601, erb2 |
| General function | |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | The pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2 positive MBC, EBC, AGC or other tumor types, and healthy volunteers, in 18 Phase I, II and III trials receiving Herceptin IV. A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile. Due to non-linear elimination, total clearance increased with decreasing concentration. Therefore, no constant value for half-life of trastuzumab can be deduced. The t1/2 decreases with decreasing concentrations within a dosing interval (see Table 16). 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/1/00/145/001 - 003 |
| 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 Pharma Biotech Penzberg Nonnenwald 2 D-82377 Penzberg Germany Genentech Inc. 1000 New Horizons Way Vacaville, CA 95688 USA Roche Singapore Technical Operations Pte. Ltd. 10 Tuas Bay Link 637394 Singapore Singapore Lonza Biologics Tuas Pte Ltd 35 Tuas South Ave. 6 637377 Singapore Singapore |
| Name and address of the manufacturer(s) responsible for batch release | Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany |
| Max shelf life | 48 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | L-histidine hydrochloride L-histidine α,α-trehalose dihydrate polysorbate 20 |
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