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%. (21)

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

Comparing Your Options
Types of Trastuzumab Biosimilar That Are Available in Malaysia

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

(Click here for the comparison data)

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)

(Click here for the comparison data)

Serious side effects

Heart problems (2.67%)

Severe lung problems (0.36%)

(6)
Trastuzumab products Original Biosimilar
Estimated cost based on 440mg injection vial RM7800.00 RM2900.00
Dosing Monotherapy

- 3 Weekly Regimes
Loading Dose: 8mg/kg (week 1) -1 cycle
Maintenance dose 3 weekly: 6mg/kg (week 2-52) – 17 cycles

- Weekly Regime
Loading Dose: 4mg/kg (week 1)
Maintenance dose weekly: 2mg/kg (week 2 -52) - 51 cycles

Combination with other chemotherapy (Physician’s Choice)

- 3 Weekly Regimes
Loading Dose: 8mg/kg (week 1) -1 cycle
Maintenance dose 3 weekly: 6mg/kg (week 2-52) – 17 cycles

- Weekly Regime
Loading Dose: 4mg/kg (week 1)
Maintenance dose weekly: 2mg/kg (week 2 -12) - 11 cycles
Subsequent dose 3 weekly: 6mg/kg (week 13-52) – 13 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.

Published Articles