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

Fresenius Kabi

Idacio (adalimumab-aacf)

Humira

Q4 2021

FDA approved Dec 14, 2022; 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

Viatris/
Fujifilm Kyowa Kirin Biologics

Hulio (adalimumab-fkjp)

Humira

Q3 2019

Approved July 6, 2020; not yet marketed

Adalimumab

Alvotech/
Teva

AVT02

Humira

November 19, 2020

FDA cited facility inspection issues September 5, 2022; FDA decision  expected Dec 2022, delayed until April 2023 

Adalimumab

Celltrion

CT-P17

Humira

November, 2020

FDA decision delayed, expected Q4 2022

Adalimumab

Coherus

Yusimry (adalimumab-aqvh)

Humira

FDA 351(k) filing December 2020

Approved Dec 20, 2021

Aflibercept

Viatris/Biocon

MYL-1701P

Eylea

Filing was expected Q4 2021, no update

Awaiting information from manufacturer

Bevacizumab

Amgen

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

Viatris/Biocon

MYL-1402O

Avastin

March 2020

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

Bevacizumab

Samsung Bioepis

SB-8

Avastin

November 19, 2019

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

Bevacizumab

Bio-Thera Solutions/
Sandoz

BAT-1706

Avastin

Filed in December 2020

FDA decision expected November 2021, delayed

Bevacizumab

Celltrion

Vegzelma (bevacizumab-adcd)

Avastin

Filed in April 2022

FDA approved September 28, 2022

Bevacizumab

Amneal/
mAbxience

Alymsys (bevacizumab-maly)

Avastin

Filed June 17, 2021

FDA approved April 14, 2022, marketed

Denosumab

Sandoz 

GP2411

Prolia/
Xgeva

February 6, 2023

FDA decision expected Q1-Q2 2024

Epoetin

Pfizer 

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

Amneal/
Kashiv

Releuko (filgrastim-ayow)

Neupogen

September 12, 2017

Approved March 1, 2022; marketed

Filgrastim

Pfizer

Nivestym (filgrastim-aafi)

Neupogen

Q4 2017

FDA approved July 20, 2018; marketed 

Filgrastim

Tanvex Biologics

TBD

Neupogen

October 1, 2018

FDA complete response letter sent Sept 25, 2019; Resubmitted application on November 22, 2020; FDA delayed May 2021 decision for inspections

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

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; not yet 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

Viatris

TBD

NovoLog

N/A

FDA rejected in Q1 2022

Natalizumab

Sandoz/
Polpharma

PB006

Tysabri

FDA application filed July 25, 2022

FDA decision possible in Q2 2023 

Pegfilgrastim

Sandoz

Ziextenzo (pegfilgrastim-bmez)

Neulasta

November 18, 2015/April 4, 2019

FDA approved November 5, 2019; marketed

Pegfilgrastim

Coherus Biosciences

Udenyca (pegfilgrastim-cbqv)

Neulasta

August 9, 2016/May 3, 2018

Approved November 2, 2018; marketed

Pegfilgrastim

Viatris/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

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; not yet marketed

Ranibizumab

Coherus Biosciences/
Bioeq/
Formycon AG

Cimerli (ranibizumab-eqrn)

Lucentis

December 2019; resubmitted August 2021

FDA approved August 2, 2022 as interchangeable; not yet marketed

Ranibizumab**

Samsung Bioepis

Byooviz (ranibizumab-nuna

Lucentis

November 18, 2020

FDA approved September 20, 2021; marketed

Ranibizumab

Xbrane Biopharm

TBD

Lucentis

FDA application filed Q1 2022 

Application withdrawn May 2022; to be resubmitted Q1 2023

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

Riabni (trastuzumab-arrx)

Rituxan

December 20, 2019

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

Tocilizumab

Fresenius Kabi

MSB11456

Actemra

August 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

Viatris/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

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 filed October 4, 2021

Potential FDA decision possible Q1 2023

Trastuzumab

Prestige Biopharma

HD201

Herceptin

FDA application to be filed Q2-3  2022

Potential FDA decision possible Q1-Q2 2023

Trastuzumab

Sandoz/
EirGenix

TBD

Herceptin

FDA application filed December 20, 2021

Potential FDA decision possible Q1 2023

 Ustekinumab

Alvotech/
Teva

 ATV02

Stelara 

 FDA application filed January 6, 2023

 FDA decision expected Q4 2023

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 February 17, 2023.

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