Blinatumomab (CD19/CD3E) – Research Grade Biosimilar

Background:

Blinatumomab is a BiTE-class (bi-specific T-cell engagers) constructed monoclonal antibody indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).Blinatumomab is manufactured by Amgen Inc.and marketed under the brand Blincyto™.Blinatumomab was approved in December 2014 under the FDA’s accelerated approval program,which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients.