Anti-CD38 (Daratumumab), Human IgG1 Antibody

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The research-grade biosimilar is a human IgG1 kappa monoclonal antibody that targets CD38, a type II transmembrane glycoprotein that is expressed on lymphoid cells, myeloid cells, and non-hematopoietic cells and performs several cell signaling functions. It is overexpressed on multiple myeloma cells. The antibody binds to CD38 and induces tumor cell death via diverse mechanisms such as antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC) and antibody-dependent cellular phagocytosis. Antibody-dependent cellular cytotoxicity is mediated by the binding of the Fc region of the antibody with FcR of NK cells; complement-dependent cytotoxicity is mediated by the binding of the Fc region of the antibody with C1q, followed by the initiation of the complement cascade; antibody-dependent cellular phagocytosis is mediated by binding of the Fc region of the antibody with the FcR of the macrophage. The original drug received FDA approval in 2015 to treat multiple myeloma