ARTG Entry
KANJINTI
ARTG entry for KANJINTI (Trastuzumab), ARTG 296881 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Amgen
- Active ingredient: Trastuzumab
- Therapeutic area: Oncology
What it is
KANJINTI is trastuzumab powder for injection available in three strengths: 60 mg, 150 mg, and 420 mg vials.
Approved indications
— Breast cancer — Gastric cancer
PBS listing
KANJINTI is listed on the PBS as a biosimilar brand with streamlined authority required restriction under Section 100 (Efficient Funding Chemotherapy Program). The brand was first listed on the ARTG on 16 May 2019.
Regulatory history
KANJINTI trastuzumab was first registered on the ARTG on 16 May 2019 with three strength variants: 60 mg, 150 mg, and 420 mg powder for injection vials. In March 2019, the PBAC recommended listing for breast cancer and gastric cancer indications as a biosimilar under Section 100 (Efficient Funding of Chemotherapy Program). In July 2019, the PBAC recommended PBS listing for all indications for which the reference brand Herceptin is PBS-listed, with streamlined authority required restriction under Section 100 (Efficient Funding Chemotherapy Program).