Out of the 3 targeted therapies (trastuzumab, pertuzumab, ado-trastuzumab emtansine), trastuzumab is the only drug that has biosimilar. Regarding the trastuzumab biosimilar, the first biosimilars being registered in Malaysia were Hertraz and Zuhera back in 2018. Herzuma was then registered in Malaysia in 2019. Due to the introduction of biosimilar, the originator brand Herceptin (which contains the active ingredient trastuzumab) has reduced their price by 52%. (23)
The following table shows the available trastuzumab brands available in Malaysia (as of 31st Dec 2020).
| No. | Product name | Active Ingredients | Holder name | Year of Registration in Malaysia |
|---|---|---|---|---|
| 1 | Herceptin (original) | Trastuzumab | Roche (Malaysia) Sdn. Bhd. | 2015 |
| 2 | Herzuma (biosimilar) | Trastuzumab | Celltrion Healthcare Malaysia Sdn. Bhd. | 2019 |
| 3 | Zuhera (biosimilar) | Trastuzumab | Biocon Sdn. Bhd. | 2018 |
| 4 | Hertraz (biosimilar) | Trastuzumab | Duopharma Sdn. Bhd. | 2018 |
| Original | Biosimilar | ||
| Brand Name | Herceptin | Herzuma | Zuhera |
|---|---|---|---|
| Active ingredient name | trastuzumab | trastuzumab-pkrb | trastuzumab (rDNA origin) |
| Indications |
Adjuvant breast cancer Metastatic breast cancer Metastatic gastric cancer |
||
| Administration Route | Intravenous Route | ||
| Duration |
Early Breast Cancer 12 months Metastatic Breast Cancer Until disease progression |
||
| Effectiveness |
No clinically meaningful difference between original product and biosimilar |
||
| Common Side Effects |
Fever (6.90%) Feeling sick to your stomach (nausea) (7.97%) Throwing up (vomiting) (4.58%) Diarrhoea (9.22%) Infections (3.15%) Increased cough (6.90%) Headache (11.95%) Feeling tired (11.77%) Shortness of breath (4.93%) Rash (5.89%) Muscle pain (5.23%) (6) |
||
| Serious Side Effects |
Heart problems (2.67%)* Severe lung problems (0.36%) (6) |
||
| Trastuzumab Products | Original | Biosimilar | |
| Estimated cost based on 440mg injection vial | RM 7250.00 | RM 2900.00 | |
*Heart problems are monitored in patients with various techniques such as multi gated acquisition (MUGA) scanning, two-dimensional echocardiography (2DE), three-dimensional echocardiography (3DE), speckle tracking echocardiography (STE) and cardiac magnetic resonance (CMR). (24)
| Types of Treatment | Dosing | |
| Adjuvant treatment HER2+ breast cancer | With concurrent paclitaxel or docetaxel | Loading dose: 4mg/kg - 1 cycle Maintenance dose (weekly): 2mg/kg - 12 cycles Subsequent dose (3-weekly): 6mg/kg - 13 cycles |
| With concurrent docetaxel/carboplatin | Loading dose: 4mg/kg - 1 cycle Maintenance dose (weekly): 2mg/kg - 18 cycles Subsequent dose (3-weekly): 6mg/kg - 11 cycles |
|
| As a single agent following completion of multimodality anthracycline-based chemotherapy | Loading dose: 8mg/kg - 1 cycle Maintenance dose: 6mg/kg - 17 cycles |
|
| Metastatic HER2+ breast cancer | Loading dose: 4mg/kg - 1 cycle Maintenance dose: 2mg/kg - 51 cycles |
|
In early breast cancer and metastatic (advanced) breast cancer, both originator/ reference product and biosimilar are comparable in terms of improving patients’ prognosis
Please refer to published articles for further information.
Last Update: 22/10/2021