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 |
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/
|
Hulio (adalimumab-fkjp) |
Humira |
Q3 2019 |
Approved July 6, 2020; marketed |
Adalimumab |
Alvotech/
|
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/
|
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/
|
Alymsys (bevacizumab-maly) |
Avastin |
Filed June 17, 2021 |
FDA approved April 14, 2022; marketed |
Denosumab |
Sandoz |
GP2411 |
Prolia/
|
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 (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 |
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/
|
Inflectra (infliximab-dyyb) |
Remicade |
Aug 8, 2014 |
Approved April 5, 2016; marketed |
Infliximab |
Samsung Bioepis/
|
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/
|
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/
|
FDA approved November 5, 2019; marketed |
Pegfilgrastim |
Coherus
|
Udenyca (pegfilgrastim-cbqv) |
Neulasta |
Aug 9, 2016/
|
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/
|
Fylnetra (pegfilgrastim-pbbk) |
Neulasta |
2021 |
FDA approved May 27, 2022; marketed |
Ranibizumab** |
Coherus
|
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/
|
Truxima (rituximab-abbs) |
Rituxan |
June 30, 2017/
|
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/
|
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/
|
Herzuma (trastuzumab-pkrb) |
Herceptin |
July 31, 2017/
|
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/
|
TBD |
Herceptin |
FDA application filed Dec 20, 2021 |
Potential FDA decision possible Q1 2023 |
Ustekinumab |
Alvotech/
|
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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