Daclizumab (IL2RA) – Research Grade Biosimilar

Background:

Humanized IgG1 Mab that binds to the human interleukin-2 receptor (anti-Tac or anti-CD25). Daclizumab is a composite of human (90%) and murine (10%) antibody sequences.The human sequences were derived from the constant domains of human IgG1 and the variable framework regions of the Eu myeloma antibody.The murine sequences were derived from the complementarity-determining regions of a murine anti-Tac antibody.On 22 April 2008,Roche Registration Limited chose to voluntarily withdraw the marketing authorization for their product Zenapax (daclizumab), as indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation and used concomitantly with an immunosuppressive regimen like cyclosporine and corticosteroids in patients who are not hight immunized,for commercial reasons and confirmed that this decision was not related to any safety concerns associated with the use of Zenapax (daclizumab) 2.Regardless of the withdrawal of Zenapax, Biogen and Abbvie's Zinbryta (daclizumab),as indicated for the treatment of adult patients with relapsing forms of multiple sclerosis,was approved for use by the FDA in 2016.