BIOSIMILAR APPROVAL STATUS IN THE US: FDA FILING DATES AND ACTIONS |
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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 (etanercept–ykro) |
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/
|
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 |
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| 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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