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

Nov 25, 2015

Approved September 23, 2016, all indications; marketed

Adalimumab**

Boehringer Ingelheim

Cyltezo (adalimumab-adbm) 

Humira

Jan 18, 2017

Approved August 29, 2017; marketed

Adalimumab

Sandoz

Hyrimoz (adalimumab-adaz)

Humira

Jan 16, 2018

Approved October 31, 2018; marketed

Adalimumab

Fresenius Kabi

Idacio (adalimumab-aacf)

Humira

Q4 2021

FDA approved Dec 14, 2022; marketed

Adalimumab

Samsung Bioepis

Hadlima (adalimumab-bwwd)

Humira

Sept 27, 2018

Approved July 22, 2019; marketed

Adalimumab

Pfizer

Abrilada (adalimumab-afzb)

Humira

Q4 2018

Approved November 18, 2019; to be marketed Q3/Q4 2023

Adalimumab

Biocon/
Fujifilm Kyowa Kirin Biologics

Hulio (adalimumab-fkjp)

Humira

Q3 2019

Approved July 6, 2020; marketed

Adalimumab

Alvotech/
Teva

AVT02

Humira

Nov 19, 2020

FDA cited facility inspection issues September 2022, April 2023, June 2023 

Adalimumab

Celltrion

Yuflyma (adalimumab-aaty)

Humira

Nov, 2020

FDA approved May 24, 2023; marketed

Adalimumab

Coherus

Yusimry (adalimumab-aqvh)

Humira

FDA 351(k) filing Dec 2020

Approved Dec 20, 2021; marketed

Aflibercept

Biocon

MYL-1701P

Eylea

FDA 351(k) filing October 2021 (by Viatris)

Approval delayed

Aflibercept

Formycon/Coherus Biosciences

FYB203

Eylea

FDA 351(k) filing June 29, 2023

FDA decision expected June 2024

Aflibercept

Celltrion

CT-P42

Eylea

FDA 351(k) filing June 30, 2023

FDA decision expected Q4 2024

Bevacizumab

Amgen

Mvasi (bevacizumab-awwb)

Avastin

Nov 15, 2016

Approved September 14, 2017; marketed

Bevacizumab

Pfizer

Zirabev (bevacizumab-bvzr)

Avastin

Aug 2018

Approved June 27, 2019; marketed

Bevacizumab

Biocon

MYL-1402O

Avastin

Mar 2020

FDA decision delayed from Dec 2020 due to inspection delays; awaiting update 

Bevacizumab

Samsung Bioepis

SB-8

Avastin

Nov 19, 2019

Samsung to resubmit at a later date, after improving manufacturing process

Bevacizumab

Bio-Thera Solutions/
Sandoz

BAT-1706

Avastin

Filed in Dec 2020

FDA decision expected November 2021, delayed

Bevacizumab

Celltrion

Vegzelma (bevacizumab-adcd)

Avastin

Filed in Apr 2022

FDA approved September 28, 2022; marketed

Bevacizumab

Amneal/
mAbxience

Alymsys (bevacizumab-maly)

Avastin

Filed June 17, 2021

FDA approved April 14, 2022; marketed

Denosumab

Sandoz 

GP2411

Prolia/
Xgeva

Feb 6, 2023

FDA decision expected Q1-Q2 2024

Eculizumab

Amgen 

ABP 959

Soliris

Feb 2023

FDA decision expected Q4 2023 or Q1 2024

Epoetin

Pfizer 

Retacrit (epoetin-epbx)

Epogen

Dec 16, 2014

Approved May 15, 2018; marketed

Etanercept

Sandoz

Erelzi (etanercept-szzs)

Enbrel

Oct 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

Amneal/
Kashiv

Releuko (filgrastim-ayow)

Neupogen

Sept 12, 2017

Approved March 1, 2022; marketed

Filgrastim

Pfizer

Nivestym (filgrastim-aafi)

Neupogen

Q4 2017

FDA approved July 20, 2018; marketed 

Filgrastim

Tanvex Biologics

TX-01

Neupogen

Oct 1, 2018

FDA rejected Sept 25, 2019; Resubmitted applications in November 2020 and August 2022 resulted in FDA rejections (most recent, Q1 2023, failed site inspection)

Infliximab

Celltrion/
Pfizer

Inflectra (infliximab-dyyb)

Remicade

Aug 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

Dec 17, 2018

Approved December 6, 2019; marketed

Insulin Glargine**

Viatris/Biocon

Semglee

Lantus

N/A

FDA approved July 28, 2021; marketed§§

Insulin Glargine**

Lilly

Rezvoglar (insulin glargine-aglr)

Lantus

N/A

FDA approved December 17, 2021; marketed

Insulin Glargine

Lannett

TBD

Lantus

N/A

Phase 3 study results to be available Q4 2022/Q1 2023 FDA application possible in 2023

Insulin Aspart

Biocon/Viatris

TBD

NovoLog

N/A

FDA rejected in Q1 2022

Natalizumab

Sandoz/
Polpharma

Tyruko (natalizumab-sztn)

Tysabri

FDA application filed July 25, 2022

FDA approval August 24, 2023; not yet marketed 

Pegfilgrastim

Sandoz

Ziextenzo (pegfilgrastim-bmez)

Neulasta

Nov 18, 2015/
Apr 4, 2019

FDA approved November 5, 2019; marketed

Pegfilgrastim

Coherus
Biosciences

Udenyca (pegfilgrastim-cbqv)

Neulasta

Aug 9, 2016/
May 3, 2018

Approved November 2, 2018; marketed

Pegfilgrastim

Biocon

Fulphila (pegfilgrastim-jmdb)

Neulasta

Feb 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

Stimufend (pegfilgrastim-fpgk)

Neulasta

May 27, 2020

FDA approved on September 6, 2022; marketed

Pegfilgastim

Lupin

TBD

Neulasta

June 2, 2021

FDA decision expected Q1 2022; delayed, no FDA action announced

Pegfilgastim

Amneal/
Kashiv

Fylnetra (pegfilgrastim-pbbk)

Neulasta

2021

FDA approved May 27, 2022; marketed

Ranibizumab**

Coherus
Biosciences/
Bioeq/
Formycon AG

Cimerli (ranibizumab-eqrn)

Lucentis

Dec 2019; resubmitted Aug 2021

FDA approved August 2, 2022 as interchangeable;  marketed

Ranibizumab

Samsung Bioepis

Byooviz (ranibizumab-nuna

Lucentis

Nov 18, 2020

FDA approved September 20, 2021; marketed

Ranibizumab

Xbrane Biopharm

TBD

Lucentis

Filed Q1 2022, withdrawn May 2022; refiled June 2023 

FDA decision expected April 21, 2024

Rituximab

Teva/
Celltrion

Truxima (rituximab-abbs)

Rituxan

June 30, 2017/
May 29, 2018

Approved November 28, 2018; marketed

Rituximab

Sandoz

Rixathon

Rituxan

Sept 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

Sept 2018

Approved July 23, 2019; marketed

Rituximab

Amgen

Riabni (trastuzumab-arrx)

Rituxan

Dec 20, 2019

FDA approved December 17, 2020; marketed

Tocilizumab

Fresenius Kabi

MSB11456

Actemra

Aug 1, 2022

FDA decision expected Q2 2023

Tocilizumab

Bio-Thera/
Biogen

BAT1806

Actemra

Dec 9, 2022

FDA decision expected Q4 2023

Trastuzumab

Pfizer

Trazimera (trastuzumab-qyyp)

Herceptin

Q3 2017

FDA approved March 11, 2019; marketed

Trastuzumab

Biocon

Ogivri (trastuzumab-dkst)

Herceptin

Nov 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

Kanjinti (trastuzumab-anns)

Herceptin

July 31, 2017

Approved June 13, 2019; marketed

Trastuzumab

Samsung Bioepis

Ontruzant (trastuzumab-dttb)

Herceptin

Dec 20, 2017

Approved January 18, 2019; marketed

Trastuzumab

Tanvex Biopharma

TBD

Herceptin

FDA application filed Oct 4, 2021

FDA complete response letter received in July 2022; resubmission expected Q4 2023

Trastuzumab

Prestige Biopharma

HD201

Herceptin

FDA application to be filed Q1-Q2  2023?

2024?

Trastuzumab

Sandoz/
EirGenix

TBD

Herceptin

FDA application filed Dec 20, 2021

Potential FDA decision possible Q1 2023

Ustekinumab

Alvotech/
Teva

 ATV02

Stelara 

FDA application filed Jan 6, 2023

FDA decision expected Q4 2023

Ustekinumab

Celltrion

 CT-P43

Stelara 

FDA application filed June 2023

FDA decision possible Q2 2024

Ustekinumab

Formycon AB

 FYB202

Stelara 

FDA application to be filed Q3 2023

 FDA decision possible Q2-Q3 2024

Blue type indicates biosimilars that have been approved by FDA.

**Designated by FDA as interchangeable with the reference product.

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

Updated September 13, 2023.

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