Russia’s Ministry of Health has registered Daratumia, the country’s first biosimilar of daratumumab, a therapy for multiple myeloma, one of the most complex chronic diseases affecting bone marrow cells. The press service of biotech company Biocad, which developed the new product, announced this information.
Daratumumab is a monoclonal antibody, a targeted molecule designed to recognize and attack tumor cells. When it binds to the CD38 protein, the drug initiates a series of immune responses resulting in the destruction of myeloma cells.
Biocad stated that clinical studies indicate daratumumab, when used in first- and second-line therapy—even in patients unsuitable for bone marrow transplant—can significantly extend survival, offering up to 5 years without disease progression and an overall survival of approximately 7.5 years.
In Russia, daratumumab is generally used as a subsequent line of therapy rather than first-line, primarily due to its high price. Biocad states that a domestic analogue will facilitate earlier access to therapy during the initial stages of treatment.
Daratumia was developed and produced in Russia in accordance with the full technological process, which includes the synthesis of the active pharmaceutical substance.
Bone marrow transplantation is regarded as a promising approach for treating oncohematological diseases, including multiple myeloma. The article explains how this method operates and discusses the factors that hinder its dissemination in Russia.