AMDB15

AMDB15 is a biosimilar monoclonal antibody currently in preclinical development by the Brazilian pharmaceutical company Blau Farmacêutica (Blausiegel Laboratory). It is designed as a biosimilar of daratumumab, a human IgG1κ monoclonal antibody that targets the CD38 antigen. CD38 is a transmembrane glycoprotein that is highly and ubiquitously expressed on the surface of multiple myeloma cells, as well as other lymphoid and myeloid cells. AMDB15 exerts its therapeutic effect by binding to CD38, which triggers tumor cell death through multiple immune-mediated mechanisms, including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC), as well as through the induction of apoptosis and inhibition of the enzymatic activity of CD38. As of 2024, the program has completed active pharmaceutical ingredient (IFA) development, with patent protection for the reference product expected to expire around 2033-2034 in the relevant market.