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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

Drug Name Approval Date More Information

Hadlima
(adalimumab-bwwd)

July 2019 Hadlima Information
Ruxience
(rituximab-pvvr)
July 2019 Ruxience Information
Zirabev
(bevacizumab-bvzr)  
June 2019  Zirabev Information
Kanjinti
(trastuzumab-anns)  
June 2019  Kanjinti Information 
Eticovo
(etanercept-ykro)
April 2019 Eticovo Information
Trazimera
(trastuzumab-qyyp)
March 2019 Trazimera Information
Ontruzant
(trastuzumab-dttb)
January 2019 Ontruzant Information
Herzuma
(trastuzumab-pkrb) 
December 2018  Herzuma Information 
Truxima
(rituximab-abbs)
November 2018  Truxima Information
Press Release: FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma
Udenyca
(pegfilgrastim-cbqv) 
November 2018  Udenyca Information 
Hyrimoz
(adalimumab-adaz)
October  2018 Hyrimoz Information
Nivestym
(filgrastim-aafi)
July 2018 Nivestym Information
Fulphila
(pegfilgrastim-jmdb)
June 2018 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 Retacrit information
Press Release: FDA approves first epoetin alfa biosimilar for the treatment of anemia
Ixifi
(infliximab-qbtx)
December 2017  Ixifi information
Ogivri
(trastuzumab-dkst)
December 2017  Ogivri information
Press Release: FDA approves first biosimilar for the treatment of certain breast and stomach cancers
Mvasi
(Bevacizumab-awwb)
September 2017 Mvasi information
Press Release: FDA approves first biosimilar for the treatment of cancer
Cyltezo
(Adalimumab-adbm)
August 2017 Cyltezo information  
Renflexis
(Infliximab-abda)
May 2017 Renflexis information
Amjevita
(Adalimumab -atto)
September 2016 Amjevita information
Press Release: FDA approves Amjevita

Erelzi
(Etanercept-szzs)
August  2016 Erelzi information
Press Release: FDA approves Erelzi
Inflectra
(Infliximab-dyyb)
April 2016   Inflectra information
Press Release: FDA approves Inflectra
Zarxio
(Filgrastim-sndz)
March 2015 Zarxio information
Press Release: FDA approves first biosimilar

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