16 FDA-approved Biosimilars


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.