Epcoritamab is a recombinant bispecific antibody designed to simultaneously bind CD20 on B cells and CD3 on T cells. This dual binding brings T cells into proximity with CD20-expressing B cells and promotes T-cell-mediated killing of malignant B cells.
Epcoritamab is also known as GEN3013 and is marketed in the United States as Epkinly in its epcoritamab-bysp form. The FDA lists it as a bispecific CD20-directed CD3 T-cell engager.
Epcoritamab is a specialized bispecific T-cell-engaging immunotherapy belonging to the biological anticancer drug class. It is designed to target CD20-positive B-cell malignancies by connecting malignant B cells with CD3-positive T cells.
The FDA-approved formulation is an injection for subcutaneous use. Current U.S. labeling includes indications in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma and follicular lymphoma (FL).
Swapnroop Drugs and Pharmaceuticals provides Epcoritamab for qualified pharmaceutical, biotechnology, oncology research and biologics-development requirements.
Because Epcoritamab is a complex recombinant bispecific antibody, its quality assessment requires biologics-specific characterization rather than conventional small-molecule API testing.
Epcoritamab binds CD20 on B cells and CD3 on T cells. This simultaneous binding facilitates interaction between T cells and CD20-positive B cells, promoting T-cell activation and cytotoxic activity against the targeted B cells.
Epcoritamab is associated with:
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |