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How many biosimilars have been approved in the United States?

What are the biosimilars for Avastin, Enbrel, Epogen, Herceptin, Humira, Neulasta, Neupogen, Remicade, and Rituxan? List of all biosimilars approved in the United States.

Medically reviewed by Judith Stewart, BPharm. Last updated on Jul 8, 2020.

Official Answer

by Drugs.com

The number of biosimilars currently approved by the FDA is twenty-eight.

The most recent biosimilar approval was Hulio (adalimumab-fkjp) on July 6, 2020.

Hulio is the sixth biosimilar to Humira.

What is a biosimilar?
According the to FDA, biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.

More information: What Are Biosimilars? Top Facts You May Not Know

Avastin (bevacizumab) Biosimilars

Enbrel (etanercept) Biosimilars

Epogen / Procrit (epoetin alfa) Biosimilars

Herceptin (trastuzumab) Biosimilars

Humira (adalimumab) Biosimilars

Neulasta (pegfilgrastim) Biosimilars

Neupogen (filgrastim) Biosimilars

Remicade (infliximab) Biosimilars

Rituxan (rituximab) Biosimilars

Biosimilar Reference Product Company FDA Approval
28 Hulio
(adalimumab-fkjp)		 Humira Mylan Pharmaceuticals Inc. July 6, 2020
27 Nyvepria
(pegfilgrastim-apgf)		 Neulasta Pfizer Inc. June 10, 2020
26 Avsola
(infliximab-axxq)		 Remicade Amgen Inc. December 6, 2019
25 Abrilada
(adalimumab-afzb)		 Humira Pfizer Inc. November 15, 2019
24 Ziextenzo
(pegfilgrastim-bmez)		 Neulasta Sandoz Inc. November 4, 2019
23 Hadlima
(adalimumab-bwwd)		 Humira Samsung Bioepis Co., Ltd. July 23, 2019
22 Ruxience
(rituximab-pvvr)		 Rituxan Pfizer Inc. July 23, 2019
21 Zirabev
(bevacizumab-bvzr)		 Avastin Pfizer Inc. June 27, 2019
20 Kanjinti
(trastuzumab-anns)		 Herceptin Amgen Inc. June 13, 2019
19 Eticovo
(etanercept-ykro)		 Enbrel Samsung Bioepis Co., Ltd. April 25, 2019
18 Trazimera
(trastuzumab-qyyp)		 Herceptin Pfizer Inc. March 11, 2019
17 Ontruzant
(trastuzumab-dttb)		 Herceptin Samsung Bioepis Co., Ltd. January 18, 2019
16 Herzuma
(trastuzumab-pkrb)		 Herceptin Celltrion, Inc. December 14, 2018
15 Truxima
(rituximab-abbs)		 Rituxan Celltrion, Inc. November 28, 2018
14 Udenyca
(pegfilgrastim-cbqv)		 Neulasta Coherus BioSciences, Inc. November 2, 2018
13 Hyrimoz
(adalimumab-adaz)		 Humira Sandoz Inc. October 30, 2018
12 Nivestym
(filgrastim-aafi)		 Neupogen Pfizer Inc. July 20, 2018
11 Fulphila
(pegfilgrastim-jmdb)		 Neulasta Mylan N.V. June 4, 2018
10 Retacrit
(epoetin alfa-epbx)		 Epogen / Procrit Hospira Inc. May 15, 2018
9 Ixifi
(infliximab-qbtx)		 Remicade Pfizer Inc. December 13, 2017
8 Ogivri
(trastuzumab-dkst)		 Herceptin Mylan GmbH December 1, 2017
7 Mvasi
(bevacizumab-awwb)		 Avastin Amgen Inc. September 14, 2017
6 Cyltezo
(adalimumab-adbm)		 Humira Boehringer Ingelheim Pharmaceuticals, Inc. August 25, 2017
5 Renflexis
(infliximab-abda)		 Remicade Samsung Bioepis Co., Ltd. April 21, 2017
4 Amjevita
(adalimumab-atto)		 Humira Amgen Inc. September 23, 2016
3 Erelzi
(etanercept-szzs)		 Enbrel Sandoz Inc. August 30, 2016
2 Inflectra
(infliximab-dyyb)		 Remicade Celltrion, Inc. April 5, 2016
1 Zarxio
(filgrastim-sndz)		 Neupogen Sandoz Inc. March 6, 2015

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