Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
| FDA-APPROVED BIOSIMILARS | ||||
|---|---|---|---|---|
| An FDA-approved biosimilar is a biological product which demonstrates that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency from the reference product, as well as meeting other criteria specified by law. An approved biosimilar is not interchangeable with its reference product, or with another biosimilar of the same reference product. | ||||
| Biosimilar | Brand | Company | Dosage Form | Indication† |
| REFERENCE PRODUCT: AVASTIN | ||||
| bevacizumab-adcd | Vegzelma | Celltrion | soln for IV infusion |
• Colorectal carcinoma • Non-squamous non-small cell lung cancer • Recurrent glioblastoma • Renal cell carcinoma • Cervical cancer • Epithelial ovarian, fallopian tube or primary peritoneal cancer |
| bevacizumab-awwb | Mvasi | Amgen | ||
| bevacizumab-bvzr | Zirabev | Pfizer | ||
| bevacizumab-maly | Alymsys | Amneal | ||
| REFERENCE PRODUCT: ENBREL | ||||
| etanercept-szzs | Erelzi* | Sandoz | soln for SC inj |
• Rheumatoid arthritis • Polyarticular juvenile idiopathic arthritis • Ankylosing spondylitis |
| etanercept-ykro | Eticovo* | Merck | soln for SC inj |
• Rheumatoid arthritis • Polyarticular juvenile idiopathic arthritis • Psoriatic arthritis • Ankylosing spondylitis • Plaque psoriasis |
| REFERENCE PRODUCT: HERCEPTIN | ||||
| trastuzumab-anns | Kanjinti | Amgen | pwd for IV infusion |
• Breast cancer • Gastric or gastroesophageal junction adenocarcinoma |
| trastuzumab-dkst | Ogivri | Mylan | ||
| trastuzumab-dttb | Ontruzant | Merck | ||
| trastuzumab-pkrb | Herzuma | Celltrion and Teva | ||
| trastuzumab-qyyp | Trazimera | Pfizer | ||
| REFERENCE PRODUCT: HUMIRA | ||||
| adalimumab-aacf | Idacio | Fresenius Kabi | soln for SC inj |
• Rheumatoid arthritis • Juvenile idiopathic arthritis • Psoriatic arthritis • Ankylosing spondylitis • Crohn’s disease • Ulcerative colitis • Plaque psoriasis • Hidradenitis suppurativa |
| adalimumab-aaty | Yuflyma | Celltrion | ||
| adalimumab-adaz | Hyrimoz | Sandoz | ||
| adalimumab-adbm | Cyltezo | Boehringer Ingelheim | ||
| adalimumab-afzb | Abrilada | Pfizer | ||
| adalimumab-atto | Amjevita | Amgen | ||
| adalimumab-aqvh | Yusimry | Coherus | ||
| adalimumab-bwwd | Hadlima | Organon and Samsung Bioepis | ||
| adalimumab-fkjp | Hulio | Biocon | ||
| REFERENCE PRODUCT: LANTUS | ||||
| insulin glargine-aglr | Rezvoglar | Eli Lilly | soln for SC inj | Diabetes |
| insulin glargine-yfgn | Semglee | Mylan | ||
| REFERENCE PRODUCT: LUCENTIS | ||||
| ranibizumab | Susvimo | Genentech | intravitreal implant |
• Neovascular (wet) age-related macular degeneration |
| ranibizumab-eqrn | Cimerli | Coherus | soln for oph intravitreal inj |
• Neovascular (wet) age-related macular degeneration • Macular edema following retinal vein occlusion • Diabetic macular edema • Diabetic retinopathy • Myopic choroidal neovascularization |
| ranibizumab-nuna | Byooviz | Biogen | soln for oph intravitreal inj |
• Neovascular (wet) age-related macular degeneration • Macular edema following retinal vein occlusion • Myopic choroidal neovascularization |
| REFERENCE PRODUCT: NEULASTA | ||||
| pegfilgrastim-apgf | Nyvepria | Pfizer | soln for SC inj | Decrease incidence of infection (febrile neutropenia) in patients on myelosuppressive chemotherapy |
| pegfilgrastim-bmez | Ziextenzo | Sandoz | ||
| pegfilgrastim-cbqv | Udenyca | Coherus Biosciences | ||
| pegfilgrastim-fpgk | Stimufend | Fresenius Kabi | ||
| pegfilgrastim-jmdb | Fulphila | Mylan | ||
| pegfilgrastim-pbbk | Fylnetra | Amneal | ||
| REFERENCE PRODUCT: NEUPOGEN | ||||
| filgrastim-aafi | Nivestym | Pfizer | soln for SC inj or IV infusion |
• Decrease incidence of infection (febrile neutropenia) in patients on myelosuppressive chemotherapy • Reduce time to neutrophil recovery and fever duration after induction/consolidation in AML • Reduce duration and incidence of neutropenia • Mobilization of hematopoietic progenitor cells |
| filgrastim-ayow | Releuko | Amneal | ||
| filgrastim-sndz | Zarxio | Sandoz | ||
| REFERENCE PRODUCT: PROCRIT OR EPOGEN | ||||
| epoetin alfa-epbx | Retacrit | Pfizer | soln for IV or SC inj |
• Anemia due to chronic kidney disease • Anemia due to zidovudine in HIV • Chemotherapy-induced anemia in patients with non-myeloid malignancies • Reduction of allogeneic red blood cell transfusion in anemic patients undergoing surgery |
| REFERENCE PRODUCT: REMICADE | ||||
| infliximab-abda | Renflexis | Merck | pwd for IV infusion |
• Rheumatoid arthritis • Psoriatic arthritis • Ankylosing spondylitis • Crohn’s disease • Ulcerative colitis • Plaque psoriasis |
| infliximab-axxq | Avsola | Amgen | ||
| infliximab-dyyb | Inflectra | Pfizer | ||
| REFERENCE PRODUCT: RITUXAN | ||||
| rituximab-abbs | Truxima | Celltrion and Teva | soln for IV infusion |
• Rheumatoid arthritis • Non-Hodgkin’s lymphoma • Chronic lymphocytic leukemia • Granulomatosis with polyangiitis (Wegener’s granulomatosis) • Microscopic polyangiitis |
| rituximab-arrx | Riabni | Amgen | soln for IV infusion |
• Non-Hodgkin’s lymphoma • Chronic lymphocytic leukemia • Granulomatosis with polyangiitis (Wegener’s granulomatosis) • Microscopic polyangiitis |
| rituximab-pvvr | Ruxience | Pfizer | soln for IV infusion |
• Rheumatoid arthritis • Non-Hodgkin’s lymphoma • Chronic lymphocytic leukemia • Granulomatosis with polyangiitis (Wegener’s granulomatosis) • Microscopic polyangiitis |
| NOTES | ||||
|
* Drug is currently pending for launch. Please contact company for estimated availability dates or for more information. Not an inclusive list. Please see drug monographs or visit www.eMPR.com. (Rev. 7/2023) |
||||
Please login or register first to view this content.
