Biosimilar Approval Status

BIOSIMILAR APPROVAL STATUS IN THE US: FDA FILING DATES AND ACTIONS

Biosimilar

Manufacturer

Brand Name & Designation

Innovator Product

FDA Filing Date

Status

Adalimumab

Amgen

Amjevita (adalimumab-atto)

Humira

November 25, 2015

Approved September 23, 2016, all indications; not yet marketed

Adalimumab

Boehringer Ingelheim

Cyltezo (adalimumab-adbm) 

Humira

January 18, 2017

Approved August 29, 2017; not yet marketed

Adalimumab

Sandoz

Hyrimoz (adalimumab-adaz)

Humira

January 16, 2018

Approved October 31, 2018

Adalimumab

Samsung Bioepis

TBD

Humira

September 27, 2018

FDA decision expected Q2-Q3 2019

Bevacizumab

Amgen/Allergan

Mvasi (bevacizumab-awwb)

Avastin

November 15, 2016

Approved September 14, 2017; not yet marketed (July 2019?)

Bevacizumab

Pfizer

Zirabev (bevacizumab-bvzr)

Avastin

August 2018

Approved June 27, 2019; not yet marketed

Epoetin

Pfizer (Hospira)

Retacrit (epoetin-epbx)

Epogen

December 16, 2014

Approved May 15, 2018

Etanercept

Sandoz

Erelzi (etanercept-szzs)

Enbrel

October 2, 2015

Approved August 31, 2016, all indications; not yet marketed

Etanercept

Samsung Bioepis

Eticovo (etanerceptykro)

Enbrel

N/A

Approved April 25, 2019; not yet marketed

Filgrastim

Sandoz

Zarxio (filgrastim-sndz)

Neupogen

May 8, 2014

Approved March 6, 2015; marketed

Filgrastim

Apotex

TBD

Neupogen

February 13, 2015

No FDA action reported (Complete response letter issued?)

Filgrastim

Pfizer

Nivestym (filgrastim-aafi)

Neupogen

Q4 2017

FDA approved July 20, 2018; marketed

Filgrastim

Kashiv Biosciences (Adello Biologics)

TBD

Neupogen

September 12, 2017

FDA decision expected Q3 2018; no FDA action reported

Filgrastim

Tanvex Biologics

TBD

Neupogen

October 1, 2018

FDA decision expected Q3 2019

Infliximab

Celltrion/Pfizer

Inflectra (infliximab-dyyb)

Remicade

August 8, 2014

Approved April 5, 2016; marketed

Infliximab

Samsung Bioepis/Merck

Renflexis (infliximab-abda)

Remicade

May 23, 2016

Approved April 21, 2017; marketed

Infliximab

Pfizer

Ixifi (infliximab-qbtx)

Remicade

April 2017

Approved December 14, 2017, all indications; will not be marketed in US

Infliximab

Amgen

TBD

Remicade

December 17, 2018

FDA decision expected Q3-Q4 2019

Insulin Glargine*

Merck/Samsung Bioepis

Lusduna

Lantus

August 5, 2016

FDA approved July 20, 2017

Insulin Glargine*

Eli Lilly

Basaglar

Lantus

October 2013

FDA approved August 2014

Pegfilgrastim

Sandoz

TBD

Neulasta

November 18, 2015/April 4, 2019

Complete response letter issued, June/July 2016; FDA decision expected Q3 2019

Pegfilgrastim

Apotex

TBD

Neulasta

December 17, 2014

No FDA action reported (Complete response letter issued?)

Pegfilgrastim

Coherus Biosciences

Udenyca (pegfilgrastim-cbqv)

Neulasta

August 9, 2016/May 3, 2018

Approved November 2, 2018; marketed

Pegfilgrastim

Mylan/Biocon

Fulphila (pegfilgrastim-jmdb)

Neulasta

February 16, 2017

FDA approved June 4, 2018; marketed

Rituximab

Teva/Celltrion

Truxima (rituximab-abbs)

Rituxan

June 30, 2017/May 29, 2018

Approved November 28, 2018; not yet marketed

Rituximab

Sandoz

Rixathon

Rituxan

September 12, 2017

FDA issued complete response letter May 2, 2018; Sandoz announced a halt to US filing effort Nov 2, 2018

Rituximab

Pfizer

TBD

Rituxan

September 2018

FDA decision expected Q2 2019

Trastuzumab

Pfizer

Trazimera (trastuzumab-qyyp)

Herceptin

Q3 2017

FDA approved March 11, 2019; not yet marketed

Trastuzumab

Mylan/Biocon

Ogivri (trastuzumab-dkst)

Herceptin

November 1, 2016

Approved December 3, 2017; not yet marketed

Trastuzumab

Teva/Celltrion

Herzuma (trastuzumab-pkrb)

Herceptin

July 31, 2017/June 18, 2018

Approved December 14, 2018; not yet marketed

Trastuzumab

Amgen/Allergan

Kanjinti (trastuzumab-anns)

Herceptin

July 31, 2017

Approved June 13, 2019; not yet marketed

Trastuzumab

Samsung Bioepis

Ontruzant (trastuzumab-dttb)

Herceptin

December 20, 2017

Approved January 18, 2019; not yet marketed

           

*Product filed as follow-on biologic (351[a]), not as a biosimilar (351[k]).

Blue type indicates biosimilars that have been approved by FDA.

Updated June 28, 2019.

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