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

Adalimumab

Mylan/Fujifilm Kyowa Kirin Biologics

Hulio (adalimumab-fkjp)

Humira

Q3 2019

Approved July 6, 2020; not yet marketed

Adalimumab

Alvotech

AVT02

Humira

November 19, 2020

FDA decision expected Q3-Q4 2021

Adalimumab

Celltrion

CT-P17

Humira

November, 2020

FDA decision expected Q3-Q4 2021

Adalimumab

Coherus

CHS-1420

Humira

FDA 351(k) filing December 2020

FDA decision expected Q4 2021

Aflibercept

Mylan

MYL-1701P

Eyelea

Filing expected Q4 2021

Potential FDA decision Q3-Q4 2022

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

Mylan/Biocon

MYL-1402O

Avastin

March 2020

FDA decision expected Q1 2021 

Bevacizumab

Samsung Bioepis

SB-8

Avastin

November 19, 2019

FDA decision expected Q1 2021

Bevacizumab

Bio-Thera Solutions

BAT-1706

Avastin

Filed in December 2020

FDA decision expected November 2021

Epoetin

Pfizer (Hospira)

Retacrit (epoetin-epbx)

Epogen

December 16, 2014

Approved May 15, 2018; marketed

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; Resubmitted application on November 22, 2020; FDA decision expected May 2021

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; marketed

Insulin Glargine

Viatris

TBD

Lantus

N/A

FDA approved as biosimilar and interchangeable July 28, 2021; marketed**

Insulin Glargine

Lannett

TBD

Lantus

N/A

FDA application possible in 2022

Insulin Aspart

Viatris

TBD

NovoLog

N/A

FDA decision possible in July 2021

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; marketed

Pegfilgastim

Fresenius Kabi

MSB11455

Neulasta

May 27, 2020

FDA decision expected Q2 2021

Pegfilgastim

Lupin

TBD

Neulasta

June 2, 2021

FDA decision expected Q1 2022

Ranibizumab

Coherus Biosciences/Bioeq/
Formycon AG

FYB-201

Lucentis

December 2019

Application was withdrawn Feb 2020 after FDA requesting additional data regarding a manufacturing change; expects to refile application in 2021

Ranibizumab

Samsung Bioepis

SB11

Lucentis

November 18, 2020

FDA decision expected Q4 2021

Ranibizumab

Xbrane Biopharm

TBD

Lucentis

FDA application to be filed Q4 2021 

FDA decision may be anticipated Q3/Q4 2022

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

Riabni (trastuzumab-arrx)

Rituxan

December 20, 2019

FDA approved December 17, 2020; to be marketed January 2021

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

Trastuzumab

Tanvex Biopharma

TBD

Herceptin

FDA application to be filed Q2-Q3 2021

Potential FDA decision possible Q2-Q3 2022

Trastuzumab

Prestige Biopharma

HD201

Herceptin

FDA application to be filed Q3-Q4 2021

Potential FDA decision possible Q3-Q4 2022

 

 

 

 

 

 

Blue type indicates biosimilars that have been approved by FDA.

**Launched in August 2020 as a 505(b)2 product. Manufacturer submitted for biosimilar status after this initial launch.

Updated August 23, 2021.

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