Ocrelizumab is a recombinant humanized monoclonal IgG1 antibody that selectively targets CD20, a surface antigen found on pre-B cells, naïve B cells, and memory B cells, but not on stem cells or plasma cells. It is approved for the treatment of primary progressive and relapsing forms of multiple sclerosis (MS), where it depletes B cells implicated in the pathogenesis of the disease through immune modulation. By binding CD20, ocrelizumab mediates B-cell lysis primarily via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, while preserving preexisting humoral immunity and the potential for B-cell reconstitution.
Ocrelizumab’s specificity for CD20 means it does not interfere with immunoglobulin production from plasma cells, reducing the risk of broad immunosuppression. Its mechanism of action centers on depleting the population of B cells that may contribute to autoantibody production and proinflammatory cytokine secretion, which are both linked to MS disease activity. Therapeutic drug monitoring (TDM) is employed in clinical and research settings to optimize dosage, ensure compliance, and track pharmacokinetics in patients undergoing ocrelizumab therapy.
Given the biologic complexity of ocrelizumab, biosimilar development and monitoring of anti-drug antibodies (ADAs) are essential. These immune responses can impact therapeutic efficacy and safety, making ADA and drug concentration assays critical tools in both research and patient care to maintain optimal treatment outcomes.
This product is manufactured in Turkey by Matriks Biotek.