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; not yet marketed

Adalimumab

Samsung Bioepis

Hadlima (adalimumab-bwwd)

Humira

September 27, 2018

Approved July 22, 2019; not yet marketed

Adalimumab

Pfizer

Abrilada (adalimumab-afzb)

Humira

Q4 2018

Approved November 18, 2019; not yet marketed

Bevacizumab

Amgen/Allergan

Mvasi (bevacizumab-awwb)

Avastin

November 15, 2016

Approved September 14, 2017; marketed

Bevacizumab

Pfizer

Zirabev (bevacizumab-bvzr)

Avastin

August 2018

Approved June 27, 2019; marketed

Bevacizumab

Samsung Bioepis

SB-8

Avastin

November 19, 2019

FDA decision expected Q4 2020

Bevacizumab

Bio-Thera Solutions

BAT-1706

Avastin

BLA to be submitted Q4 2020

Potentially Q3/Q4 2021

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 complete response letter sent Sept 25, 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

Avasola (infliximab-axxq)

Remicade

December 17, 2018

Approved December 6, 2019; not yet marketed

Insulin Glargine

Lannett

TBD

Lantus

N/A

FDA application possible in 2022

Pegfilgrastim

Sandoz

Ziextenzo (pegfilgrastim-bmez)

Neulasta

November 18, 2015/April 4, 2019

FDA approved November 5, 2019; marketed

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

Pegfilgastim

Pfizer

Nyvepria (pegfilgrastim-apgf)

Neulasta

Q3 2019

FDA approved June 11, 2020; not yet marketed

Pegfilgastim

Fresenius Kabi

MSB11455

Neulasta

May 27, 2020

FDA decision expected Q2 2021

Ranibizumab

Coherus Biosciences/Bioeq

TBD

Lucentis

December 2019

FDA decision expected Q4 2020

Ranibizumab

Samsung Bioepis

SB11

Lucentis

FDA Application filing expected Q2/Q3 2020

FDA decision expected 2021

Rituximab

Teva/Celltrion

Truxima (rituximab-abbs)

Rituxan

June 30, 2017/May 29, 2018

Approved November 28, 2018; 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

Ruxience (rituximab-pvvr)

Rituxan

September 2018

Approved July 23, 2019; marketed

Rituximab

Amgen/Allergan

ABP 798

Rituxan

December 20, 2019

FDA decision expected Q4 2020

Trastuzumab

Pfizer

Trazimera (trastuzumab-qyyp)

Herceptin

Q3 2017

FDA approved March 11, 2019; marketed

Trastuzumab

Mylan/Biocon

Ogivri (trastuzumab-dkst)

Herceptin

November 1, 2016

Approved December 3, 2017; marketed

Trastuzumab

Teva/Celltrion

Herzuma (trastuzumab-pkrb)

Herceptin

July 31, 2017/June 18, 2018

Approved December 14, 2018; marketed

Trastuzumab

Amgen/Allergan

Kanjinti (trastuzumab-anns)

Herceptin

July 31, 2017

Approved June 13, 2019; marketed

Trastuzumab

Samsung Bioepis

Ontruzant (trastuzumab-dttb)

Herceptin

December 20, 2017

Approved January 18, 2019; marketed

 

 

 

 

 

 

Blue type indicates biosimilars that have been approved by FDA.

Updated June 15, 2020.

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