FDA-Approved Biosimilars

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-awwb	Mvasi	Amgen	soln for IV infusion	• Metastatic colorectal cancer • Unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer • Recurrent glioblastoma • Metastatic renal cell carcinoma • Persistent, recurrent, or metastatic cervical cancer
bevacizumab-bvzr	Zirabev	Pfizer	soln for IV infusion
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 • Metastatic 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-adaz	Hyrimoz*	Sandoz	soln for SC inj	• Rheumatoid arthritis • Juvenile idiopathic arthritis • Psoriatic arthritis • Ankylosing spondylitis • Crohn’s disease • Ulcerative colitis • Plaque psoriasis
adalimumab-adbm	Cyltezo*	Boehringer Ingelheim
adalimumab-afzb	Abrilada*	Pfizer
adalimumab-atto	Amjevita*	Amgen
adalimumab-bwwd	Hadlima*	Merck
REFERENCE PRODUCT: NEULASTA
pegfilgrastim-bmez	Ziextenzo*	Sandoz	soln for SC inj	Decrease incidence of infection (febrile neutropenia) in patients on myelosuppressive chemotherapy
pegfilgrastim-cbqv	Udenyca	Coherus Biosciences
pegfilgrastim-jmdb	Fulphila	Mylan
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-sndz	Zarxio	Sandoz	soln for SC inj or IV infusion
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
infliximab-qbtx	Ixifi*	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-pvvr	Ruxience	Pfizer	soln for IV infusion	• 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. ^† See drug monographs or full labeling for detailed description of indications. Not an inclusive list. Please see drug monographs or visit www.eMPR.com. (Rev. 4/2020)

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