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  8. Biosimilar Product Information
  1. Biosimilars

Biosimilar Product Information

The Food and Drug Administration approves biosimilar products and provides the scientific and regulatory advice needed to bring safe and effective biosimilars to market. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.

FDA-Approved Biosimilar Products

Biosimilar Name Approval Date Reference Product More Information
Hulio (adalimumab-fkjp) July 2020 Humira (adalimumab) Humira Information
Nyvepria (pegfilgrastim-apgf) June 2020 Neulasta (pegfilgrastim) Nyvepria Information
Avsola (infliximab-axxq) December 2019 Remicade (infliximab) Avsola Information
Abrilada (adalimumab-afzb) November 2019 Humira (adalimumab) Abrilada Information
Ziextenzo
(pegfilgrastim-bmez)
November 2019 Neluasta (pegfilgrastim) Ziextenzo Information
Hadlima
(adalimumab-bwwd)
July 2019 Humira (adalimumab) Hadlima Information
Ruxience
(rituximab-pvvr)
July 2019 Rituxan (rituximab) Ruxience Information
Zirabev
(bevacizumab-bvzr)  
June 2019  Avastin (bevacizumab) Zirabev Information
Kanjinti
(trastuzumab-anns)  
June 2019  Herceptin (trastuzumab) Kanjinti Information 
Eticovo
(etanercept-ykro)
April 2019 Enbrel (etanercept) Eticovo Information
Trazimera
(trastuzumab-qyyp)
March 2019 Herceptin (trastuzumab) Trazimera Information
Ontruzant
(trastuzumab-dttb)
January 2019 Herceptin (trastuzumab) Ontruzant Information
Herzuma
(trastuzumab-pkrb) 
December 2018  Herceptin (trastuzumab) Herzuma Information 
Truxima
(rituximab-abbs)
November 2018  Rituxan (rituximab) Truxima Information
Press Release: FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma
Udenyca
(pegfilgrastim-cbqv) 
November 2018  Neulasta (pegfilgrastim) Udenyca Information 
Hyrimoz
(adalimumab-adaz)
October  2018

Humira (adalimumab)

Hyrimoz Information
Nivestym
(filgrastim-aafi)
July 2018 Neupogen (filgrastim) Nivestym Information
Fulphila
(pegfilgrastim-jmdb)
June 2018 Neluasta (pegfilgrastim) Fulphila Information
Press Release: FDA approves first biosimilar to Neulasta to help reduce the risk   of infection during cancer treatment
Retacrit
(epoetin alfa-epbx)
May 2018 Epogen (epoetin-alfa) Retacrit information
Press Release: FDA approves first epoetin alfa biosimilar for the treatment of anemia
Ixifi
(infliximab-qbtx)
December 2017  Remicade (infliximab) Ixifi information
Ogivri
(trastuzumab-dkst)
December 2017  Herceptin (trastuzumab) Ogivri information
Press Release: FDA approves first biosimilar for the treatment of certain breast and stomach cancers
Mvasi
(Bevacizumab-awwb)
September 2017 Avastin (bevacizumab) Mvasi information
Press Release: FDA approves first biosimilar for the treatment of cancer
Cyltezo
(Adalimumab-adbm)
August 2017 Humira (adalimumab) Cyltezo information  
Renflexis
(Infliximab-abda)
May 2017 Remicade (infliximab) Renflexis information
Amjevita
(Adalimumab -atto)
September 2016 Humira (adalimumab) Amjevita information
Press Release: FDA approves Amjevita
Erelzi
(Etanercept-szzs)
August  2016 Enbrel (etanercept) Erelzi information
Press Release: FDA approves Erelzi
Inflectra
(Infliximab-dyyb)
April 2016   Remicade (infliximab) Inflectra information
Press Release: FDA approves Inflectra
Zarxio
(Filgrastim-sndz)
March 2015 Neupogen (filgrastim) Zarxio information
Press Release: FDA approves first biosimilar

Learn More

  • The "Purple Book" is available as a searchable, online database that contains information about all FDA-licensed biological products regulated by the Center for Drug Evaluation and Research (CDER), including biosimilar and interchangeable biological products, and a list containing information about all FDA-licensed biological products regulated by the Center for Biologics Evaluation.

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