| 16 FDA-approved Biosimilars | ||||
|---|---|---|---|---|
| Shaded rows indicate products on the market as of Jan. 14, 2019 | ||||
| Biosimilar trade name (nonproprietary name, manufacturer) | Indications | Reference product trade name (generic name, manufacturer) | ||
| 1 | Herzuma (trastuzumab-pkrb, Celltrion and Teva) | Dec. 2018 | Treatment of HER2-overexpressing breast cancer | Herceptin (trastuzumab, Genentech) |
| 2 | Truxima (rituximab-abbs, Celltrion) | Nov. 2018 | Treatment of CD20-positive, B-cell, non-Hodgkin’s lymphoma | Rituxan (rituximab, Genentech) |
| 3 | Udenyca (pegfilgrastim-cbqv, Coherus BioSciences) | Nov. 2018 | Reduction of infection risk in patients with nonmyeloid cancer receiving myelosuppressive chemotherapy | Neulasta (pegfilgrastim, Amgen) |
| 4 | Hyrimoz (adalimumab-adaz, Sandoz) | Oct. 2018 | Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, plaque psoriasis | Humira (adalimumab, AbbVie) |
| 5 | Nivestym (filgrastim-aafi, Pfizer) | July 2018 | Reduction of infection risk in patients receiving myelosuppressive chemotherapy, reduction of time to neutrophil recovery and duration of fever in patients with AML receiving induction or consolidation therapy, reduction of neutropenia in patients undergoing bone marrow transplantation, mobilization of hematopoietic progenitor cells for collection by leukapheresis, reduction of severe neutropenia in patients with congenital, cyclic, or idiopathic neutropenia | Neupogen (filgrastim, Amgen) |
| 6 | Fulphila (pegfilgrastim-jmdb, Mylan) | June 2018 | Reduction of infection risk in patients with nonmyeloid cancers receiving myelosuppressive therapy | Neulasta (pegfilgrastim, Amgen) |
| 7 | Retacrit (epoetin alfa-epbx, Hospira*) | May 2018 | Treatment of patients with anemia caused by chronic kidney disease, treatment with zidovudine for HIV infection, or myelosuppressivec chemotherapy. Reduction of blood transfusions in people undergoing elective surgery. | Epogen (epoetin alfa, Amgen) and Procrit (epoetin alfa, Janssen) |
| 8 | Ixifi (infliximab-qbtx, Pfizer) | Dec. 2017 | Treatment of Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis | Remicade (infliximab, Janssen) |
| 9 | Ogivri (trastuzumab-dkst, Mylan) | Dec. 2017 | Treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma | Herceptin (trastuzumab, Genentech) |
| 10 | Mvasi (bevacizumab-awwb, Amgen) | Sept. 2017 | Treatment of metastatic colorectal cancer, nonsquamous non–small-cell lung cancer, glioblastoma, metastatic renal cell cancer, cervical cancer | Avastin (bevacizumab, Genentech) |
| 11 | Cyltezo (adalimumab-adbm, Boehringer Ingelheim) | Aug. 2017 | Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, plaque psoriasis | Humira (adalimumab, AbbVie) |
| 12 | Renflexis (infliximab-abda, Merck) | May 2017 | Treatment of Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis | Remicade (infliximab, Janssen) |
| 13 | Amjevita (adalimumab-atto, Amgen) | Sept. 2016 | Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, plaque psoriasis | Humira (adalimumab, AbbVie) |
| 14 | Erelzi (etanercept-szzs, Sandoz) | Aug. 2016 | Treatment of rheumatoid arthritis, polyarticular juvenile arthritis, psoriatic arthritis, ankylosing spondylitis | Enbrel (etanercept, Amgen) |
| 15 | Inflectra (infliximab-dyyb, Celltrion and Pfizer) | April 2016 | Treatment of Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis | Remicade (infliximab, Janssen) |
| 16 | Zarxio (filgrastim-sndz, Sandoz) | March 2015 | Reduction of infection risk in patients receiving myelosuppressive chemotherapy, reduction of time to neutrophil recovery and duration of fever in patients with AML receiving induction or consolidation therapy, reduction of neutropenia in patients undergoing bone marrow transplantation, mobilization of hematopoietic progenitor cells for collection by leukapheresis, reduction of severe neutropenia in patients with congenital, cyclic, or idiopathic neutropenia | Neupogen (filgrastim, Amgen) |
| *Hospira is a subsidiary of Pfizer. | ||||
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