Biosimilar Trastuzumab

    Project Code: 171
    Trastuzumab is a recombinant DNA-derived humanized monoclonal antibody that is used in treatment of breast cancer. This biosimilar version of trastuzumab shows high bioequivalence to market versions of the drug
Project Overview
The innovation is a biosimilar trastuzumab that was designed and produced in-house by the company. Although trastuzumab has side effects such as flu-like symptoms (such as fever, chills and mild pain), nausea, diarrhea, an association with cardiac dysfunction (in 2-7% of cases), and a contraindication with anthracycline chemotherapy, this biosimilar variant has shown reduced occurrence of such side effects.

The product is available in two variants:
• A single-dose vial containing 60 or 150 mg of Trastuzumab
• 440 mg/21 ml multi-dose vials 

It can be administered in an outpatient setting. The recommended loading dose is 4mg/kg as a 90-minute intravenous infusion along with 175 mg/m2/ dose on day 1 of therapy. 

The weekly maintenance dose is 2 mg/kg over 30 minutes if the first dose was well tolerated on days 1, 8, and 15 except for day 1 of the first cycle.


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