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Where Is a List of Biosimilar Drugs and Biologics That Have Been Approved in the U.S.?

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Where Is a List of Biosimilar Drugs and Biologics That Have Been Approved in the U.S.?

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Where is a list of all biosimilar drugs that have been approved in the U.S.?

The FDA maintains a list of biosimilar drugs that have been approved in the USA. This list can be found here.

What biosimilar drugs have been approved in the USA?

The following biosimilar drugs have been approved in the U.S.:

Biosimilar Drug NameApproval DateReference Product
Zarxio (Filgrastim)March 2015Neupogen
Inflectra
(Infliximab)
April 2016Remicade
Erelzi
(Etanercept)
April 2016Enbrel
Amjevita
(Adalimumab)
September 2016Humira
Renflexis
(Infliximab)
May 2017Remicade
Cyltezo
(Adalimumab)
August 2017Humira
Mvasi
(Bevacizumab)
September 2017Avastin
Ogivri
(trastuzumab)
December 2017Herceptin
Ixifi
(infliximab)
December 2017Remicade
 

Where is a list of all biologics that have been approved in the U.S.?

The FDA maintains a list of approved biologics cataloged by year and archived back to 2014 here.

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