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 pwd for IV infusion
trastuzumab-dttb Ontruzant* Merck pwd for IV infusion
trastuzumab-pkrb Herzuma* Celltrion and Teva pwd for IV infusion
trastuzumab-qyyp Trazimera* Pfizer pwd for IV infusion
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 soln for SC inj
adalimumab-atto Amjevita* Amgen soln for SC inj
adalimumab-bwwd Hadlima* Merck soln for SC inj
REFERENCE PRODUCT: NEULASTA
pegfilgrastim-cbqv Udenyca Coherus Biosciences soln for SC inj Decrease incidence of infection (febrile neutropenia) in patients on myelosuppressive chemotherapy
pegfilgrastim-jmdb Fulphila Mylan soln for SC inj
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-dyyb Inflectra Pfizer pwd for IV infusion
infliximab-qbtx Ixifi* Pfizer pwd for IV infusion
REFERENCE PRODUCT: RITUXAN
rituximab-abbs Truxima* Celltrion and Teva soln for IV infusion

• Non-Hodgkin’s lymphoma

• Chronic lymphocytic leukemia

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.

Created 7/2019

This article originally appeared on MPR