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Trastucip and Tuzucip
Published
Product name
Trastucip and Tuzucip
Active ingredient
trastuzumab
Submission type
New biosimilar medicine
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Trastucip and Tuzucip (trastuzumab) was approved for the following therapeutic uses:
Early breast cancer
Trastucip and Tuzucip are indicated for the treatment of HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.
Locally advanced breast cancer
Trastucip and Tuzucip are indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant Trastucip and Tuzucip.
Metastatic breast cancer
Trastucip and Tuzucip are indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2:
- as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;
- in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or
- in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer
Advanced gastric cancer
Trastucip and Tuzucip are indicated in combination with cisplatin and either capecitabine or 5-FU for the treatment of patients with HER2 positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
How this medicine works
Tuzucip and Trastucip are biosimilar medicine to Herceptin. The human epidermal growth factor receptor 2 (HER2 or c erbB2) proto oncogene encodes for a single transmembrane spanning, receptor like protein of 185 kilodalton (kDa), which is structurally related to the epidermal growth factor receptor.
Trastuzumab has been shown, both in in-vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2. In vitro, trastuzumab-mediated antibody dependent cell mediated cytotoxicity (ADCC) has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2. In animal models in vivo, murine anti-HER2 antibody inhibited the growth of human tumours overexpressing HER2, indicating that the humanised antibody (trastuzumab) is likely also to have anti-proliferative activity in vivo against human breast tumours expressing high levels of HER2.
Sponsor