This page, updated at least monthly, tracks all US FDA-approved biosimilars, including approval dates, launch status, interchangeability designations, manufacturers, and reference products. In addition, it tracks any FDA biosimilar approval application (351k), for which information has been publicly disclosed.
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 |
Abatacept |
Dr. Reddy’s Laboratories |
DRL_AB |
Orencia |
December 2025 |
FDA decision expected Q4 2026 |
Adalimumab |
Amgen |
Amjevita (adalimumab-atto) |
Humira |
Nov 25, 2015 |
Approved September 23, 2016 |
Adalimumab |
Boehringer Ingelheim |
Cyltezo (adalimumab-adbm)Â |
Humira |
Jan 18, 2017 |
Approved August 29, 2017 |
Adalimumab |
Sandoz |
Hyrimoz (adalimumab-adaz) |
Humira |
Jan 16, 2018 |
Approved October 31, 2018 |
Adalimumab |
Fresenius Kabi |
Idacio (adalimumab-aacf) |
Humira |
Q4 2021 |
FDA approved Dec 14, 2022 |
Adalimumab |
Samsung Bioepis |
Hadlima (adalimumab-bwwd) |
Humira |
Sept 27, 2018 |
Approved July 22, 2019 |
Adalimumab |
Pfizer |
Abrilada (adalimumab-afzb) |
Humira |
Q4 2018 |
Approved November 18, 2019 |
Adalimumab |
Biocon/
|
Hulio (adalimumab-fkjp) |
Humira |
Q3 2019 |
Approved July 6, 2020 |
Adalimumab |
Alvotech/
|
Simlandi (adalimumab-ryvk) |
Humira |
Nov 19, 2020 |
Approved Feb 23, 2024Â |
Adalimumab |
Celltrion |
Yuflyma (adalimumab-aaty) |
Humira |
Nov, 2020 |
FDA approved May 24, 2023 |
Adalimumab |
Meitheal |
Yusimry (adalimumab-aqvh) |
Humira |
FDA 351(k) filing Dec 2020 |
Approved Dec 20, 2021; acquired from Coherus |
Aflibercept |
Amgen |
Pavblu (aflibercept-ayyh) |
Eylea |
FDA 351(k) filing Q3 2023 |
FDA approval August 24, 2024 |
Aflibercept |
Samsung Bioepis/
|
Opuviz (aflibercept-yszy) |
Eylea |
FDA 351(k) filing Q3 2023 (unconfirmed) |
FDA approval on May 20, 2024, not yet marketed |
Aflibercept |
Lupin |
LUBT010 |
Eylea |
FDA filing estimated in Q4 2025 |
FDA decision estimated Q4 2026 |
Aflibercept |
Sandoz |
Enzeevu (aflibercept-abzv) |
Eylea |
FDA 351(k) filing Q3 2023 (unconfirmed) |
FDA approval on August 12, 2024, not yet marketed |
Aflibercept |
Biocon |
Yesafili (aflibercept-jbvf) |
Eylea |
FDA 351(k) filing October 2021 (by Viatris) |
FDA approval on May 20, 2024, not yet marketed |
Aflibercept |
Alvotech/Teva |
AVT06 |
Eylea |
FDA filing accepted Feb 18, 2025 |
FDA CRL issued Nov 24, 2025; application resubmitted June 4, 2026 |
Aflibercept |
Formycon |
Ahzantive
|
Eylea |
FDA 351(k) filing June 29, 2023 |
FDA approved July 1, 2024, not yet marketed |
Aflibercept |
Celltrion |
Eydenzelt (aflibercept-boav) |
Eylea |
FDA 351(k) filing June 30, 2023 |
FDA approved Oct 10, 2025 |
Bevacizumab |
Amgen |
Mvasi (bevacizumab-awwb) |
Avastin |
Nov 15, 2016 |
Approved September 14, 2017 |
Bevacizumab |
Pfizer |
Zirabev (bevacizumab-bvzr) |
Avastin |
Aug 2018 |
Approved June 27, 2019 |
Bevacizumab |
Biocon |
Jobevne (bevacizumab-nwgo) |
Avastin |
Original filing, Mar 2020 |
FDA approved April 10, 2025 |
Bevacizumab |
Bio-Thera Solutions/
|
Avzivi |
Avastin |
Original filing, Dec 2020 |
FDA approved Dec 7, 2023 |
Bevacizumab |
Celltrion |
Vegzelma
|
Avastin |
Filed in Apr 2022 |
FDA approved September 28, 2022 |
Bevacizumab |
Amneal/
|
Alymsys (bevacizumab-maly) |
Avastin |
Filed June 17, 2021 |
FDA approved April 14, 2022Â |
Denosumab |
Sandoz |
Jubbonti/
|
Prolia/
|
Feb 6, 2023 |
FDA approved March 5, 2024 |
Denosumab |
Samsung Bioepis |
Ospomyv/
|
Prolia/
|
Q1 2023 |
FDA approved Feb 16, 2024 |
Denosumab |
Frensenius Kabi |
Conexxence/
|
Prolia/Xgeva |
May 27, 2024 |
FDA approval March 26, 2025 |
Denosumab |
Gedeon Richter/Hikma |
Enoby/Xtrenbo (denosumab-qbde) |
Prolia/Xgeva |
Oct 2024(?) |
FDA approval October 14, 2025 |
Denosumab |
Biocon Biologics |
Bosaya/Aukelso (denosumab-kyqq) |
Prolia/Xgeva |
Not announced |
FDA approval September 17, 2025, not yet marketed |
Denosumab |
Alvotech/Dr. Reddy’s |
AVT03 |
Prolia/Xgeva |
March 18, 2025 |
FDA decision expected Q1 2026 |
Denosumab |
Shanghai Henlius/
|
Bildyos/
|
Prolia/
|
Oct 30, 2024 |
FDA approved September 2, 2025 |
Denosumab |
Amneal/
|
Boncresa/
|
Prolia/
|
March 3, 2025 |
FDA approved December 22, 2025 |
Denosumab |
Accord BioPharma |
Osvyrti/Jubereq (denosumab-desu) |
Prolia/
|
N/A |
FDA approved Nov 20, 2025 |
Denosumab |
Teva |
Ponlimsi (denosumab-adet) |
Prolia |
October 2024 |
FDA approved March 30, 2026 (not approved for Xgeva indications) |
Denosumab |
Celltrion |
Stoboclo/
|
Prolia/
|
Nov 30, 2023 |
FDA approved March 3, 2025 |
Eculizumab |
Amgen |
Bkemv (eculizumab-aeeb) |
Soliris |
Feb 2023 |
FDA approved May 28, 2024 |
Eculizumab |
Samsung Bioepis |
Epysqli (eculizumab-aagh) |
Soliris |
July 7, 2023 |
FDA approved July 22, 2024 |
Epoetin |
Pfizer |
Retacrit (epoetin-epbx) |
Epogen |
Dec 16, 2014 |
Approved May 15, 2018 |
Etanercept |
Sandoz |
Erelzi (etanercept-szzs) |
Enbrel |
Oct 2, 2015 |
Approved August 31, 2016, all indications; not yet marketed |
Etanercept |
Samsung Bioepis |
Eticovo
|
Enbrel |
N/A |
Approved April 25, 2019; not yet marketed |
Filgrastim |
Sandoz |
Zarxio (filgrastim-sndz) |
Neupogen |
May 8, 2014 |
Approved March 6, 2015 |
Filgrastim |
Amneal/
|
Releuko (filgrastim-ayow) |
Neupogen |
Sept 12, 2017 |
Approved March 1, 2022 |
Filgrastim |
Pfizer |
Nivestym (filgrastim-aafi) |
Neupogen |
Q4 2017 |
FDA approved July 20, 2018 |
Filgrastim |
Accord BioPharma |
Filkri (filgrastim-laha) |
Neupogen |
N/A |
FDA approved February 17, 2026 |
Filgrastim |
Tanvex Biologics |
Nypozi (filgrastim-txid) |
Neupogen |
Oct 1, 2018 |
FDA approved June 28, 2024, not yet marketed |
Golimumab |
Alvotech/Teva |
AVT05 |
Simponi |
Jan 27, 2025 |
CRL issued November 2025, FDA application resubmitted June 4, 2026Â |
Golimumab |
Bio-Thera Solutions/ Accord BioPharm |
Immgolis/Immgolis Intri (golimumab-sldi) |
Simponi/Simponi Aria |
May 16, 2025 |
Approved May 15, 2026 |
Infliximab |
Celltrion/
|
Inflectra (infliximab-dyyb) |
Remicade |
Aug 8, 2014 |
Approved April 5, 2016 |
Infliximab |
Samsung Bioepis/
|
Renflexis (infliximab-abda) |
Remicade |
May 23, 2016 |
Approved April 21, 2017 |
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, 2019Â |
Insulin Glargine |
Viatris/Biocon |
Semglee |
Lantus |
N/A |
FDA approved July 28, 2021§§ |
Insulin Glargine |
Sandoz |
TBD |
Lantus |
FDA filing Feb 2023 |
FDA decision expected Q1 2024, no FDA action reported |
Insulin Glargine |
Lilly |
Rezvoglar (insulin glargine-aglr) |
Lantus |
N/A |
FDA approved December 17, 2021 |
Insulin Glargine |
Lannett |
TBD |
Lantus |
N/A |
FDA filing date or info not updated; company filed for and emerged from Chapter 11 bankruptcy in June 2023Â |
Insulin Aspart |
Biocon |
Kirsty (inulin aspart-xjhz) |
Novolog |
FDA filing in July 2020 |
FDA approved July 15, 2025 |
Insulin Aspart |
Sandoz |
TBD |
Novolog |
FDA filing in June 2023 |
FDA decision expected Q2-3 2024, No FDA action reported |
Insulin Aspart |
Sanofi Aventis |
Merilog (insulin aspart-szjj) |
Novolog |
N/A |
FDA approved Feb 14, 2025 |
Insulin Lispro |
Sandoz |
TBD |
Humalog |
FDA filing in June 2023 |
FDA decision expected Q2-3 2024, No FDA action reported |
Natalizumab |
Sandoz/
|
Tyruko (natalizumab-sztn) |
Tysabri |
FDA application filed July 25, 2022 |
FDA approval August 24, 2023 |
Omalizumab |
Celltrion |
Omlyclo (omalizumab-igec)** |
Xolair |
FDA application filed March 2024 |
FDA approved March 9, 2025; not yet marketed |
Omalizumab |
Tevs |
TEV-45779 |
Xolair |
FDA application accepted March 30, 2026 |
FDA decision expected Q1 2027 |
Omalizumab |
Amneal Biosciences/
|
ADL-018 |
Xolair |
FDA application filed Sept 26, 2025 |
FDA decision expected Q3 2026 |
Pegfilgrastim |
Sandoz |
Ziextenzo (pegfilgrastim-bmez) |
Neulasta |
Nov 18, 2015/
|
FDA approved November 5, 2019 |
Pegfilgrastim |
Intas/Accord BioPharma |
Udenyca (pegfilgrastim-cbqv) |
Neulasta |
Aug 9, 2016/
|
Approved November 2, 2018 |
Pegfilgrastim |
Biocon |
Fulphila (pegfilgrastim-jmdb) |
Neulasta |
Feb 16, 2017 |
FDA approved June 4, 2018Â |
Pegfilgrastim |
Pfizer |
Nyvepria (pegfilgrastim-apgf) |
Neulasta |
Q3 2019 |
FDA approved June 11, 2020 |
Pegfilgrastim |
Fresenius Kabi |
Stimufend (pegfilgrastim-fpgk) |
Neulasta |
May 27, 2020 |
FDA approved on September 6, 2022 |
Pegfilgrastim |
Lupin |
Armlupeg (pegfilgrastim-unne) |
Neulasta |
June 2, 2021 |
FDA approved November 30, 2025 |
Pegfilgrastim |
Amneal/
|
Fylnetra (pegfilgrastim-pbbk) |
Neulasta |
2021 |
FDA approved May 27, 2022Â |
Pertuzumab |
Henlius/
|
Poherdy (pertuzumab-dpzb) |
Perjeta |
2024 |
FDA approved November 17, 2025; not yet marketed |
Pertuzumab |
Eirgenix/
|
EG12014 |
Perjeta |
2025 |
FDA issued a CRL Dec 9, 2026 |
Ranibizumab |
Sandoz/
|
Cimerli (ranibizumab-eqrn) |
Lucentis |
Dec 2019; resubmitted Aug 2021 |
FDA approved August 2, 2022 |
Ranibizumab |
Samsung Bioepis |
Byooviz (ranibizumab-nuna) |
Lucentis |
Nov 18, 2020 |
FDA approved September 20, 2021 |
Ranibizumab |
Formycon AG/Zydus |
Nufymco (ranibizumab-leyk) |
Lucentis |
Filed Q4 2024 |
FDA approved December 2025 |
Ranibizumab |
Xbrane Biopharm |
TBD |
Lucentis |
Filed Q1 2022, withdrawn May 2022; refiled June 2023;Â Â |
FDA rejected April 2024 (data query and failed site inspection) |
Rituximab |
Teva/
|
Truxima (rituximab-abbs) |
Rituxan |
June 30, 2017/
|
Approved November 28, 2018Â |
Rituximab |
Sandoz |
Rixathon |
Rituxan |
Sept 12, 2017 |
FDA issued CRL 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 |
Rituximab |
Amgen |
Riabni (rituximab-arrx) |
Rituxan |
Dec 20, 2019 |
FDA approved December 17, 2020 |
Rituximab |
Fresenius Kabi/Dr. Reddy’s Laboratories |
DRL_RI |
Rituxan |
July 2023 |
FDA decision not reported |
Tocilizumab |
Fresenius Kabi |
Tyenne (tocilizumab-aazg) |
Actemra |
Aug 1, 2022 |
FDA approved March 7, 2024 |
Tocilizumab |
Bio-Thera/
|
Tofidence (tocilizumab-bavi)Â |
Actemra |
Dec 9, 2022 |
FDA approved Sept 29, 2023Â |
Tocilizumab |
Celltrion |
Avtozma (tocilizumab-anoh) |
Actemra |
Jan 28, 2024 |
FDA approved Jan 31, 2025 |
Trastuzumab |
Pfizer |
Trazimera (trastuzumab-qyyp) |
Herceptin |
Q3 2017 |
FDA approved March 11, 2019 |
Trastuzumab |
Biocon |
Ogivri (trastuzumab-dkst) |
Herceptin |
Nov 1, 2016 |
Approved December 3, 2017 |
Trastuzumab |
Teva/
|
Herzuma (trastuzumab-pkrb) |
Herceptin |
July 31, 2017/
|
Approved December 14, 2018 |
Trastuzumab |
Amgen |
Kanjinti (trastuzumab-anns) |
Herceptin |
July 31, 2017 |
Approved June 13, 2019 |
Trastuzumab |
Samsung Bioepis |
Ontruzant (trastuzumab-dttb) |
Herceptin |
Dec 20, 2017 |
Approved January 18, 2019 |
Trastuzumab |
Tanvex Biopharma |
TBD |
Herceptin |
FDA application filed Oct 4, 2021 |
FDA CRL received in July 2022; second CRL received January 2025 |
Trastuzumab |
Prestige Biopharma |
HD201 |
Herceptin |
FDA application to be filed Q1-Q2Â 2023? |
No information update |
Trastuzumab |
Accord Biopharma/ Shanghai Henlius |
Hercessi (trastuzumab-strf) |
Herceptin |
FDA application filed April 2023 |
FDA approved April 29, 2024 |
Trastuzumab |
Sandoz/
|
EG12014 |
Herceptin |
FDA application filed Dec 20, 2021 |
Latest FDA CRL received Dec 5, 2024 |
Ustekinumab |
Amgen |
 Wezlana (ustekinumab-auub) |
Stelara |
FDA application filed Q3 2022 |
FDA approval Oct 31, 2023 |
Ustekinumab |
Alvotech/
|
Selarsdi (ustekinumab-aekn) |
Stelara |
FDA application filed Jan 6, 2023 |
FDA approved April 16, 2024 |
Ustekinumab |
Samsung Bioepis/
|
Pyzchiva (ustekinumab-ttwe) |
Stelara |
FDA application filed Q2 2023 |
FDA approved July 1, 2024 |
Ustekinumab |
Accord/Intas |
Imuldosa (ustekinumab-srif) |
Stelara |
FDA application filed Jan 4, 2024 |
FDA approved Oct 14, 2024 |
Ustekinumab |
Celltrion |
Steqeyma (ustekinumab-stba) |
Stelara |
FDA application filed June 2023 |
FDA approved December 17, 2024 |
Ustekinumab |
Biocon |
Yesintek (ustekinumab-kfce) |
Stelara |
FDA application filed Feb 2024 |
FDA approved Dec 2, 2024 |
Ustekinumab |
Formycon AG/Fresenius Kabi |
 Otulfi (ustekinumab-aauz) |
Stelara |
FDA application to be filed Q4 2023 |
FDA approved Sept 30, 2024 |
Ustekinumab |
Bio-Thera/Hikma |
Starjemza (usteminumab-hmny |
Stelara |
FDA application filed July 24, 2024 |
FDA approved May 27, 2025 |
Vedolizumab |
Alvotech/Teva |
AVT16 |
Entyvio |
FDA application accepted June 8, 2026 |
FDA decision expected Q2 2027 |
| Blue type indicates biosimilars that have been approved by FDA. CRL = Complete response letter (i.e., FDA rejection of application).
§§Launched in August 2020 as a 505(b)2 product. Manufacturer submitted for biosimilar status after this initial launch. Updated June 9, 2026. |
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