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 |
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/
|
Hulio (adalimumab-fkjp) |
Humira |
Q3 2019 |
Approved July 6, 2020; not yet marketed |
Adalimumab |
Alvotech/
|
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/
|
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/
|
Alymsys (bevacizumab-maly) |
Avastin |
Filed June 17, 2021 |
FDA approved April 14, 2022, marketed |
Denosumab |
Sandoz |
GP2411 |
Prolia/
|
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 (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 |
Amneal/
|
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/
|
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/
|
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/
|
Fylnetra (pegfilgrastim-pbbk) |
Neulasta |
2021 |
FDA approved May 27, 2022; not yet marketed |
Ranibizumab |
Coherus Biosciences/
|
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/
|
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/
|
TBD |
Herceptin |
FDA application filed December 20, 2021 |
Potential FDA decision possible Q1 2023 |
Ustekinumab |
Alvotech/
|
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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