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BCD-022 is a biosimilar monoclonal antibody to trastuzumab developed by Biocad for the treatment of HER2-positive malignancies, particularly metastatic breast cancer. It is an IgG1 humanized monoclonal antibody targeting the extracellular domain of the human epidermal growth factor receptor 2 (HER2/ErbB2), inhibiting HER2-mediated signaling and inducing antibody-dependent cellular cytotoxicity, thereby suppressing tumor cell proliferation and survival.[1][4] Phase I and III studies have demonstrated pharmacokinetic and clinical similarity to reference trastuzumab, including equivalent overall response rates and safety when combined with paclitaxel in metastatic HER2-positive breast cancer.[1][3][4] BCD-022 received marketing approval in Russia as a trastuzumab biosimilar for HER2-positive breast cancer and has also been developed for HER2-positive gastric cancer.[3][9][10]
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