Table 1. A summary list of the biosimilars currently affirmed in the United States and their proposed indications.
Source: [18]
FDA: U.S. Food and Drug Administration; HER2: human epidermal growth factor receptor 2
| Biosimilar | Reference Drug | FDA Approval Timeline | Mechanism of Action(s) | Clinical Indications |
| Filgrastim-sndz1 (Zarxio) | Filgrastim (Neupogen/ Amgen) | 2015 | Granulocyte colony-stimulating factor | Acute myeloid leukemia, Severe neutropenia, patient on chronic immunosuppressive therapy, or those undergoing stem cell or bone marrow transplant. |
| Infliximab-dyyb (Inflectra) | Infliximab (Remicade) | 2016 | Tumor necrosis factor-alpha inhibitor | Juvenile idiopathic arthritis, Rheumatoid arthritis, Inflammatory bowel disease (Crohn’s disease or ulcerative colitis), and seronegative spondyloarthropathies. |
| Etanercept-szzs (Erelzi) | Etanercept (Enbrel) | 2016 | Tumor necrosis factor-alpha inhibitor | Severe active psoriatic disease, juvenile idiopathic arthritis, severe polyarticular juvenile idiopathic disease. |
| Adalimumab-atto (Amjevita) | Adalimumab (Humira) | 2016 | Tumor necrosis factor-alpha inhibitor | Rheumatoid arthritis, severe seronegative polyarticular disease, and inflammatory bowel disease |
| Infliximab-abda (Renflexis) | Infliximab (Remicade) | 2017 | Tumor necrosis factor-alpha inhibitor | Inflammatory bowel disease, rheumatoid arthritis, seronegative spondyloarthropathies. |
| Trastuzumab-dkst (Ogivri) | Trastuzumab (Herceptin) | 2017 | HER2 receptor inhibitor | HER2 receptor-positive metastatic breast disease, gastro-esophageal junction metastatic disease. |
| Epoetin Alfa-epbx (Retacrit) | Epoetin Alfa (Epogen/ Procrit) | 2018 | Erythropoietin | Anemia, cancer, chronic kidney failure |
| Pegfilgrastim-jmdb (Fulphilia) | Pegfilgrastim (Neulasta) | 2018 | Granulocyte colony-stimulating factor | Decrease the risk of infection in non-myeloid cancer who are receiving myelosuppressive chemotherapy |
| Filgrastim-aafi (Nivestym) | Filgrastim (Neupogen) | 2018 | Leukocyte growth factor | Reduce the frequency of febrile neutropenia and infections in patients with non-myeloid malignancies receiving immune-suppressive therapy. |