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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


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
Humira Mylan Pharmaceuticals Inc. July 6, 2020
27 Nyvepria
Neulasta Pfizer Inc. June 10, 2020
26 Avsola
Remicade Amgen Inc. December 6, 2019
25 Abrilada
Humira Pfizer Inc. November 15, 2019
24 Ziextenzo
Neulasta Sandoz Inc. November 4, 2019
23 Hadlima
Humira Samsung Bioepis Co., Ltd. July 23, 2019
22 Ruxience
Rituxan Pfizer Inc. July 23, 2019
21 Zirabev
Avastin Pfizer Inc. June 27, 2019
20 Kanjinti
Herceptin Amgen Inc. June 13, 2019
19 Eticovo
Enbrel Samsung Bioepis Co., Ltd. April 25, 2019
18 Trazimera
Herceptin Pfizer Inc. March 11, 2019
17 Ontruzant
Herceptin Samsung Bioepis Co., Ltd. January 18, 2019
16 Herzuma
Herceptin Celltrion, Inc. December 14, 2018
15 Truxima
Rituxan Celltrion, Inc. November 28, 2018
14 Udenyca
Neulasta Coherus BioSciences, Inc. November 2, 2018
13 Hyrimoz
Humira Sandoz Inc. October 30, 2018
12 Nivestym
Neupogen Pfizer Inc. July 20, 2018
11 Fulphila
Neulasta Mylan N.V. June 4, 2018
10 Retacrit
(epoetin alfa-epbx)
Epogen / Procrit Hospira Inc. May 15, 2018
9 Ixifi
Remicade Pfizer Inc. December 13, 2017
8 Ogivri
Herceptin Mylan GmbH December 1, 2017
7 Mvasi
Avastin Amgen Inc. September 14, 2017
6 Cyltezo
Humira Boehringer Ingelheim Pharmaceuticals, Inc. August 25, 2017
5 Renflexis
Remicade Samsung Bioepis Co., Ltd. April 21, 2017
4 Amjevita
Humira Amgen Inc. September 23, 2016
3 Erelzi
Enbrel Sandoz Inc. August 30, 2016
2 Inflectra
Remicade Celltrion, Inc. April 5, 2016
1 Zarxio
Neupogen Sandoz Inc. March 6, 2015

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