FDA-approved biosimilars
Every biosimilar and interchangeable biologic licensed by the FDA, grouped by the reference product it copies.
The FDA has licensed 95 biosimilar products under section 351(k), 51 of them designated interchangeable, copying 21 reference biologics. Xgeva (denosumab) has the most, with 12. The most recent is Abrilada (adalimumab-afzb), licensed on . An interchangeable biosimilar may be substituted for its reference product at the pharmacy, subject to state law.
All FDA biosimilars, newest first
95 products| Biosimilar | Reference product | Company | Licensed |
|---|---|---|---|
| Abrilada Interchangeable adalimumab-afzb · BLA 761118 |
Humira adalimumab |
Pfizer Inc. | |
| Ahzantive aflibercept-mrbb · BLA 761378 |
Eylea aflibercept |
Formycon AG | |
| Alymsys bevacizumab-maly · BLA 761231 |
Avastin bevacizumab |
Amneal Pharmaceuticals LLC | |
| Amjevita Interchangeable adalimumab-atto · BLA 761024 |
Humira adalimumab |
Amgen Inc. | |
| Armlupeg pegfilgrastim-unne · BLA 761212 |
Neulasta pegfilgrastim |
Lupin Limited (Biotech Division) | |
| Aukelso Interchangeable denosumab-kyqq · BLA 761436 |
Xgeva denosumab |
Biocon Biologics Inc. | |
| Avsola infliximab-axxq · BLA 761086 |
Remicade infliximab |
Amgen Inc. | |
| Avtozma Interchangeable tocilizumab-anoh · BLA 761498 |
Actemra tocilizumab |
CELLTRION, Inc. | |
| Avtozma Interchangeable tocilizumab-anoh · BLA 761420 |
Actemra tocilizumab |
CELLTRION, Inc. | |
| Avzivi bevacizumab-tnjn · BLA 761198 |
Avastin bevacizumab |
Bio-Thera Solutions, Ltd. | |
| Bildyos Interchangeable denosumab-nxxp · BLA 761444 |
Prolia denosumab |
Shanghai Henlius Biotech, Inc. | |
| Bkemv Interchangeable eculizumab-aeeb · BLA 761333 |
Soliris eculizumab |
Amgen Inc. | |
| Bomyntra Interchangeable denosumab-bnht · BLA 761398 |
Xgeva denosumab |
Fresenius Kabi USA, LLC | |
| Boncresa Interchangeable denosumab-mobz · BLA 761456 |
Prolia denosumab |
Amneal Pharmaceuticals LLC | |
| Byooviz Interchangeable ranibizumab-nuna · BLA 761202 |
Lucentis ranibizumab |
Samsung Bioepis Co., Ltd. | |
| Cimerli Interchangeable ranibizumab-eqrn · BLA 761165 |
Lucentis ranibizumab |
Sandoz Inc. | |
| Cyltezo Interchangeable adalimumab-adbm · BLA 761058 |
Humira adalimumab |
Boehringer Ingelheim Pharmaceuticals, Inc. | |
| Degevma Interchangeable denosumab-adet · BLA 761481 |
Xgeva denosumab |
Teva Pharmaceuticals, Inc. | |
| Ennumo pegfilgrastim-pccg · BLA 761147 |
Neulasta pegfilgrastim |
Accord BioPharma Inc. | |
| Enoby Interchangeable denosumab-qbde · BLA 761439 |
Prolia denosumab |
Hikma Pharmaceuticals USA Inc. | |
| Enzeevu aflibercept-abzv · BLA 761382 |
Eylea aflibercept |
Sandoz Inc. | |
| Epysqli Interchangeable eculizumab-aagh · BLA 761340 |
Soliris eculizumab |
Samsung Bioepis Co., Ltd. | |
| Erelzi etanercept-szzs · BLA 761042 |
Enbrel etanercept |
Sandoz Inc. | Discontinued |
| Eticovo Interchangeable etanercept-ykro · BLA 761066 |
Enbrel etanercept |
Samsung Bioepis Co., Ltd. | Discontinued |
| Eydenzelt aflibercept-boav · BLA 761377 |
Eylea aflibercept |
CELLTRION, Inc. | |
| Filkri filgrastim-laha · BLA 761027 |
Neupogen filgrastim |
Accord BioPharma Inc. | |
| Fulphila pegfilgrastim-jmdb · BLA 761075 |
Neulasta pegfilgrastim |
Biocon Biologics Inc. | |
| Fylnetra pegfilgrastim-pbbk · BLA 761084 |
Neulasta pegfilgrastim |
Kashiv BioSciences, LLC | |
| Garzulys Interchangeable insulin aspart-fsan · BLA 761497 |
Novolog insulin aspart |
Emerge Bioscience Pte. Ltd. | |
| Hadlima Interchangeable adalimumab-bwwd · BLA 761059 |
Humira adalimumab |
Samsung Bioepis Co., Ltd. | |
| Hercessi trastuzumab-strf · BLA 761346 |
Herceptin trastuzumab |
Accord BioPharma Inc. | |
| Herzuma trastuzumab-pkrb · BLA 761091 |
Herceptin trastuzumab |
CELLTRION, Inc. | |
| Hulio Interchangeable adalimumab-fkjp · BLA 761154 |
Humira adalimumab |
Biocon Biologics Inc. | |
| Hyrimoz Interchangeable adalimumab-adaz · BLA 761071 |
Humira adalimumab |
Sandoz Inc. | |
| Idacio adalimumab-aacf · BLA 761255 |
Humira adalimumab |
Fresenius Kabi USA, LLC | |
| Immgolis Interchangeable golimumab-sldi · BLA 761452 |
Simponi golimumab |
Accord BioPharma Inc. | |
| Imuldosa Interchangeable ustekinumab-srlf · BLA 761364 |
Stelara ustekinumab |
Accord BioPharma Inc. | |
| Inflectra infliximab-dyyb · BLA 125544 |
Remicade infliximab |
CELLTRION, Inc. | |
| Ixifi infliximab-qbtx · BLA 761072 |
Remicade infliximab |
Pfizer Ireland Pharmaceuticals Unlimited Company | Discontinued |
| Jobevne bevacizumab-nwgd · BLA 761175 |
Avastin bevacizumab |
Biocon Biologics Inc. | |
| Jubbonti Interchangeable denosumab-bbdz · BLA 761362 |
Prolia denosumab |
Sandoz Inc. | |
| Jubereq Interchangeable denosumab-desu · BLA 761424 |
Xgeva denosumab |
Accord BioPharma Inc. | |
| Kanjinti trastuzumab-anns · BLA 761073 |
Herceptin trastuzumab |
Amgen Inc. | |
| Kirsty Interchangeable insulin aspart-xjhz · BLA 761188 |
Novolog insulin aspart |
Biocon Biologics Inc. | |
| Langlara Interchangeable insulin glargine-aldy · BLA 761412 |
Lantus insulin glargine |
Sunshine Lake Pharma Co., Ltd. | |
| Merilog insulin aspart-szjj · BLA 761325 |
Novolog insulin aspart |
Sanofi-Aventis U.S. LLC | |
| Mvasi bevacizumab-awwb · BLA 761028 |
Avastin bevacizumab |
Amgen Inc. | |
| Nivestym filgrastim-aafi · BLA 761080 |
Neupogen filgrastim |
Hospira Inc., a Pfizer Company | |
| Nufymco Interchangeable ranibizumab-leyk · BLA 761473 |
Lucentis ranibizumab |
Zydus Lifesciences Global FZE | |
| Nypozi filgrastim-txid · BLA 761126 |
Neupogen filgrastim |
Tanvex BioPharma USA, Inc. | |
| Nyvepria pegfilgrastim-apgf · BLA 761111 |
Neulasta pegfilgrastim |
Hospira Inc., a Pfizer Company | |
| Ogivri trastuzumab-dkst · BLA 761074 |
Herceptin trastuzumab |
Biocon Biologics Inc. | |
| Omlyclo Interchangeable omalizumab-igec · BLA 761399 |
Xolair omalizumab |
CELLTRION, Inc. | |
| Ontruzant trastuzumab-dttb · BLA 761100 |
Herceptin trastuzumab |
Samsung Bioepis Co., Ltd. | |
| Opuviz Interchangeable aflibercept-yszy · BLA 761350 |
Eylea aflibercept |
Samsung Bioepis Co., Ltd. | |
| Osenvelt Interchangeable denosumab-bmwo · BLA 761404 |
Xgeva denosumab |
CELLTRION, Inc. | |
| Ospomyv Interchangeable denosumab-dssb · BLA 761392 |
Prolia denosumab |
Samsung Bioepis Co., Ltd. | |
| Otulfi Interchangeable ustekinumab-aauz · BLA 761379 |
Stelara ustekinumab |
Fresenius Kabi USA, LLC | |
| Oziltus Interchangeable denosumab-mobz · BLA 761457 |
Xgeva denosumab |
Amneal Pharmaceuticals LLC | |
| Pavblu aflibercept-ayyh · BLA 761298 |
Eylea aflibercept |
Amgen Inc. | |
| Poherdy Interchangeable pertuzumab-dpzb · BLA 761450 |
Perjeta pertuzumab |
Shanghai Henlius Biotech, Inc. | |
| Ponlimsi Interchangeable denosumab-adet · BLA 761385 |
Prolia denosumab |
Teva Pharmaceuticals, Inc. | |
| Pyzchiva Interchangeable ustekinumab-ttwe · BLA 761373 |
Stelara ustekinumab |
Samsung Bioepis Co., Ltd. | |
| Pyzchiva Interchangeable ustekinumab-ttwe · BLA 761425 |
Stelara ustekinumab |
Samsung Bioepis Co., Ltd. | |
| Ranluspec Interchangeable ranibizumab-hkdz · BLA 761480 |
Lucentis ranibizumab |
Lupin Limited (Biotech Division) | |
| Releuko filgrastim-ayow · BLA 761082 |
Neupogen filgrastim |
Kashiv BioSciences, LLC | |
| Renflexis infliximab-abda · BLA 761054 |
Remicade infliximab |
Samsung Bioepis Co., Ltd. | |
| Retacrit epoetin alfa-epbx · BLA 125545 |
Procrit epoetin alfa |
Hospira Inc., a Pfizer Company | |
| Rezvoglar Interchangeable insulin glargine-aglr · BLA 761215 |
Lantus insulin glargine |
Eli Lilly and Company | |
| Riabni rituximab-arrx · BLA 761140 |
Rituxan rituximab |
Amgen Inc. | |
| Ruxience rituximab-pvvr · BLA 761103 |
Rituxan rituximab |
Pfizer Ireland Pharmaceuticals Unlimited Company | |
| Selarsdi Interchangeable ustekinumab-aekn · BLA 761343 |
Stelara ustekinumab |
Alvotech USA Inc. | |
| Semglee Interchangeable insulin glargine-yfgn · BLA 761201 |
Lantus insulin glargine |
Biocon Biologics Inc. | |
| Simlandi Interchangeable adalimumab-ryvk · BLA 761299 |
Humira adalimumab |
Alvotech USA Inc. | |
| Starjemza Interchangeable ustekinumab-hmny · BLA 761419 |
Stelara ustekinumab |
Bio-Thera Solutions, Ltd. | |
| Steqeyma Interchangeable ustekinumab-stba · BLA 761338 |
Stelara ustekinumab |
CELLTRION, Inc. | |
| Stimufend pegfilgrastim-fpgk · BLA 761173 |
Neulasta pegfilgrastim |
Fresenius Kabi USA, LLC | |
| Tofidence tocilizumab-bavi · BLA 761354 |
Actemra tocilizumab |
Biogen MA Inc. | |
| Trazimera trastuzumab-qyyp · BLA 761081 |
Herceptin trastuzumab |
Pfizer Ireland Pharmaceuticals Unlimited Company | |
| Truxima Interchangeable rituximab-abbs · BLA 761088 |
Rituxan rituximab |
CELLTRION, Inc. | |
| Tyenne tocilizumab-aazg · BLA 761275 |
Actemra tocilizumab |
Fresenius Kabi USA, LLC | |
| Tyenne tocilizumab-aazg · BLA 761449 |
Actemra tocilizumab |
Fresenius Kabi USA, LLC | |
| Tyruko natalizumab-sztn · BLA 761322 |
Tysabri natalizumab |
Sandoz Inc. | |
| Udenyca pegfilgrastim-cbqv · BLA 761039 |
Neulasta pegfilgrastim |
Accord BioPharma Inc. | |
| Vegzelma bevacizumab-adcd · BLA 761268 |
Avastin bevacizumab |
CELLTRION, Inc. | |
| Wezlana Interchangeable ustekinumab-auub · BLA 761285 |
Stelara ustekinumab |
Amgen Inc. | |
| Wezlana Interchangeable ustekinumab-auub · BLA 761331 |
Stelara ustekinumab |
Amgen Inc. | |
| Yesafili Interchangeable aflibercept-jbvf · BLA 761274 |
Eylea aflibercept |
Biocon Biologics Inc. | |
| Yesintek Interchangeable ustekinumab-kfce · BLA 761406 |
Stelara ustekinumab |
Biocon Biologics Inc. | |
| Yuflyma Interchangeable adalimumab-aaty · BLA 761219 |
Humira adalimumab |
CELLTRION, Inc. | |
| Yusimry Interchangeable adalimumab-aqvh · BLA 761216 |
Humira adalimumab |
Emerge Bioscience Pte. Ltd. | |
| Zarxio filgrastim-sndz · BLA 125553 |
Neupogen filgrastim |
Sandoz Inc. | |
| Ziextenzo pegfilgrastim-bmez · BLA 761045 |
Neulasta pegfilgrastim |
Sandoz Inc. | |
| Zimrixby rituximab-cdxx · BLA 761376 |
Rituxan rituximab |
Dr. Reddy's Laboratories SA | |
| Zirabev bevacizumab-bvzr · BLA 761099 |
Avastin bevacizumab |
Pfizer Inc. |
Biosimilars by reference biologic
21 reference productsXgeva (denosumab) · 12 biosimilars
Aukelso , interchangeable · Bildyos , interchangeable · Bomyntra , interchangeable · Boncresa , interchangeable · Degevma , interchangeable · Enoby , interchangeable · Jubbonti , interchangeable · Jubereq , interchangeable · Osenvelt , interchangeable · Ospomyv , interchangeable · Oziltus , interchangeable · Ponlimsi , interchangeable
24 clinical trials →Humira (adalimumab) · 10 biosimilars
Abrilada , interchangeable · Amjevita , interchangeable · Cyltezo , interchangeable · Hadlima , interchangeable · Hulio , interchangeable · Hyrimoz , interchangeable · Idacio · Simlandi , interchangeable · Yuflyma , interchangeable · Yusimry , interchangeable
38 clinical trials →Stelara (ustekinumab) · 10 biosimilars
Imuldosa , interchangeable · Otulfi , interchangeable · Pyzchiva , interchangeable · Pyzchiva , interchangeable · Selarsdi , interchangeable · Starjemza , interchangeable · Steqeyma , interchangeable · Wezlana , interchangeable · Wezlana , interchangeable · Yesintek , interchangeable
25 clinical trials →Neulasta (pegfilgrastim) · 8 biosimilars
Armlupeg · Ennumo · Fulphila · Fylnetra · Nyvepria · Stimufend · Udenyca · Ziextenzo
17 clinical trials →Eylea (aflibercept) · 6 biosimilars
Ahzantive · Enzeevu · Eydenzelt · Opuviz , interchangeable · Pavblu · Yesafili , interchangeable
45 clinical trials →Avastin (bevacizumab) · 6 biosimilars
Alymsys · Avzivi · Jobevne · Mvasi · Vegzelma · Zirabev
435 clinical trials →Herceptin (trastuzumab) · 6 biosimilars
Hercessi · Herzuma · Kanjinti · Ogivri · Ontruzant · Trazimera
148 clinical trials →Neupogen (filgrastim) · 5 biosimilars
Filkri · Nivestym · Nypozi · Releuko · Zarxio
17 clinical trials →Actemra (tocilizumab) · 5 biosimilars
Avtozma , interchangeable · Avtozma , interchangeable · Tofidence · Tyenne · Tyenne
71 clinical trials →Lucentis (ranibizumab) · 4 biosimilars
Byooviz , interchangeable · Cimerli , interchangeable · Nufymco , interchangeable · Ranluspec , interchangeable
13 clinical trials →Rituxan (rituximab) · 4 biosimilars
Riabni · Ruxience · Truxima , interchangeable · Zimrixby
253 clinical trials →Novolog (insulin aspart) · 3 biosimilars
Garzulys , interchangeable · Kirsty , interchangeable · Merilog
3 clinical trials →Lantus (insulin glargine) · 3 biosimilars
Langlara , interchangeable · Rezvoglar , interchangeable · Semglee , interchangeable
4 clinical trials →Soliris (eculizumab) · 2 biosimilars
Bkemv , interchangeable · Epysqli , interchangeable
13 clinical trials →How this page is built
Every row is copied from the FDA's Purple Book monthly data file. Only products licensed under section 351(k) of the Public Health Service Act (biosimilars and interchangeables) are listed.
- FDA Purple Book: Database of Licensed Biological Products ↗ BLA number, proprietary and proper names, licence type (351(k) biosimilar or interchangeable), applicant, reference product, approval and interchangeability dates, marketing status
A weekly job downloads the newest Purple Book monthly data file, keeps 351(k) products and groups their presentations by BLA number. The licence date is the earliest approval date among a BLA's presentations. No AI drafting and no editorial pass. See our editorial standards. The the FDA data on this page was last retrieved on 12 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.