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) ** |
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 decision expected Q4 2025 |
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 |
Samsung Bioepis |
SB-8 |
Avastin |
Nov 19, 2019 |
Samsung to resubmit at a later date, after improving manufacturing process |
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 |
TVB-009 |
Prolia/
|
October 2024 |
FDA decision expected Q4 2025 |
Denosumab** |
Celltrion |
Stoboclo/
|
Prolia/
|
Nov 30, 2023 |
FDA approved March 3, 2025; not yet marketed |
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 2025Â |
Golimumab |
Bio-Thera Solutions/ Accord BioPharm |
BAT2506 |
Simponi |
May 16, 2025 |
FDA decision expected May 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; not yet marketed |
Omalizumab |
Celltrion |
Omlyclo (omalizumab-igec)** |
Xolair |
FDA application filed March 2024 |
FDA approved March 9, 2025; not yet marketed |
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 |
Pegfilgastim |
Pfizer |
Nyvepria (pegfilgrastim-apgf) |
Neulasta |
Q3 2019 |
FDA approved June 11, 2020 |
Pegfilgastim |
Fresenius Kabi |
Stimufend (pegfilgrastim-fpgk) |
Neulasta |
May 27, 2020 |
FDA approved on September 6, 2022 |
Pegfilgastim |
Lupin |
Armlupeg (pegfilgrastim-unne) |
Neulasta |
June 2, 2021 |
FDA approved November 30, 2025 |
Pegfilgastim |
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 |
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 |
| Blue type indicates biosimilars that have been approved by FDA. CRL = Complete response letter (i.e., FDA rejection of application).
**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 26, 2026. |
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