Product Dossier

TRAZIMERA

Product Dossier for TRAZIMERA (Trastuzumab, Pfizer). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

TRAZIMERA is trastuzumab supplied as a powder for injection in vials of 60 mg or 150 mg. Trastuzumab is a monoclonal antibody that targets the human epidermal growth factor receptor-2 (HER2).

Approved indications

— HER2 positive breast cancer. — HER2 positive gastric cancer.

PBS listing

TRAZIMERA is listed on the PBS as a biosimilar trastuzumab for all indications for which the reference brand Herceptin® is PBS listed, with authority required (streamlined) restrictions.

Regulatory history

TRAZIMERA was first listed on the ARTG on 19 August 2019. The PBAC recommended listing in November 2019 under Section 100 (Efficient Funding of Chemotherapy).