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Trastuzumab (Instituto Vital Brasil) is a biosimilar version of the monoclonal antibody trastuzumab, originally developed by Roche as Herceptin. It is being developed by the Brazilian state-owned laboratory Instituto Vital Brasil in partnership with Bionovis and Merck KGaA as part of Brazil's Partnerships for Productive Development (PDP) program. This initiative facilitates technology transfer to enable the domestic production of high-cost biologic medicines. The drug is a recombinant IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 (HER2). By targeting HER2, it inhibits the proliferation of tumor cells that overexpress this receptor, which is a characteristic of certain aggressive forms of breast and gastric cancers. The development program includes indications for both early-stage and metastatic HER2-positive breast cancer as well as gastric cancer.
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