Every biosimilar and interchangeable biologic licensed by the FDA, grouped by the reference product it copies.
The FDA has licensed 94 biosimilar products under section 351(k), 48 of them designated interchangeable, copying 21 reference biologics. Prolia (denosumab) has the most, with 11. The most recent is Zimrixby (rituximab-cdxx), licensed on 31 Jul 2026. An interchangeable biosimilar may be substituted for its reference product at the pharmacy, subject to state law.
| Biosimilar | Reference product | Company | Licensed |
|---|---|---|---|
| Zimrixby rituximab-cdxx · BLA 761376 |
Rituxan rituximab |
Dr. Reddy's Laboratories SA | 31 Jul 2026 |
| Garzulys insulin aspart-fsan · BLA 761497 |
Novolog insulin aspart |
Emerge Bioscience Pte. Ltd. | 24 Jul 2026 |
| Immgolis Interchangeable golimumab-sldi · BLA 761452 |
Simponi golimumab |
Accord BioPharma Inc. | 15 May 2026 |
| Langlara Interchangeable insulin glargine-aldy · BLA 761412 |
Lantus insulin glargine |
Sunshine Lake Pharma Co., Ltd. | 29 Apr 2026 |
| Ponlimsi Interchangeable denosumab-adet · BLA 761385 |
Prolia denosumab |
Teva Pharmaceuticals, Inc. | 27 Mar 2026 |
| Filkri filgrastim-laha · BLA 761027 |
Neupogen filgrastim |
Accord BioPharma Inc. | 15 Jan 2026 |
| Boncresa Interchangeable denosumab-mobz · BLA 761456 |
Prolia denosumab |
Amneal Pharmaceuticals LLC | 19 Dec 2025 |
| Oziltus Interchangeable denosumab-mobz · BLA 761457 |
Xgeva denosumab |
Amneal Pharmaceuticals LLC | 19 Dec 2025 |
| Nufymco Interchangeable ranibizumab-leyk · BLA 761473 |
Lucentis ranibizumab |
Zydus Lifesciences Global FZE | 18 Dec 2025 |
| Armlupeg pegfilgrastim-unne · BLA 761212 |
Neulasta pegfilgrastim |
Lupin Limited (Biotech Division) | 28 Nov 2025 |
| Poherdy Interchangeable pertuzumab-dpzb · BLA 761450 |
Perjeta pertuzumab |
Shanghai Henlius Biotech, Inc. | 13 Nov 2025 |
| Jubereq Interchangeable denosumab-desu · BLA 761424 |
Xgeva denosumab |
Accord BioPharma Inc. | 29 Oct 2025 |
| Enoby Interchangeable denosumab-qbde · BLA 761439 |
Prolia denosumab |
Hikma Pharmaceuticals USA Inc. | 26 Sep 2025 |
| Aukelso Interchangeable denosumab-kyqq · BLA 761436 |
Xgeva denosumab |
Biocon Biologics Inc. | 16 Sep 2025 |
| Bildyos Interchangeable denosumab-nxxp · BLA 761444 |
Prolia denosumab |
Shanghai Henlius Biotech, Inc. | 29 Aug 2025 |
| Kirsty Interchangeable insulin aspart-xjhz · BLA 761188 |
Novolog insulin aspart |
Biocon Biologics Inc. | 15 Jul 2025 |
| Starjemza Interchangeable ustekinumab-hmny · BLA 761419 |
Stelara ustekinumab |
Bio-Thera Solutions, Ltd. | 22 May 2025 |
| Bomyntra Interchangeable denosumab-bnht · BLA 761398 |
Xgeva denosumab |
Fresenius Kabi USA, LLC | 25 Mar 2025 |
| Tyenne tocilizumab-aazg · BLA 761449 |
Actemra tocilizumab |
Fresenius Kabi USA, LLC | 14 Mar 2025 |
| Osenvelt Interchangeable denosumab-bmwo · BLA 761404 |
Xgeva denosumab |
CELLTRION, Inc. | 28 Feb 2025 |
| Merilog insulin aspart-szjj · BLA 761325 |
Novolog insulin aspart |
Sanofi-Aventis U.S. LLC | 14 Feb 2025 |
| Ospomyv Interchangeable denosumab-dssb · BLA 761392 |
Prolia denosumab |
Samsung Bioepis Co., Ltd. | 13 Feb 2025 |
| Avtozma Interchangeable tocilizumab-anoh · BLA 761498 |
Actemra tocilizumab |
CELLTRION, Inc. | 24 Jan 2025 |
| Avtozma Interchangeable tocilizumab-anoh · BLA 761420 |
Actemra tocilizumab |
CELLTRION, Inc. | 24 Jan 2025 |
| Steqeyma Interchangeable ustekinumab-stba · BLA 761338 |
Stelara ustekinumab |
CELLTRION, Inc. | 17 Dec 2024 |
| Yesintek Interchangeable ustekinumab-kfce · BLA 761406 |
Stelara ustekinumab |
Biocon Biologics Inc. | 29 Nov 2024 |
| Imuldosa Interchangeable ustekinumab-srlf · BLA 761364 |
Stelara ustekinumab |
Accord BioPharma Inc. | 10 Oct 2024 |
| Otulfi Interchangeable ustekinumab-aauz · BLA 761379 |
Stelara ustekinumab |
Fresenius Kabi USA, LLC | 27 Sep 2024 |
| Pavblu aflibercept-ayyh · BLA 761298 |
Eylea aflibercept |
Amgen Inc. | 23 Aug 2024 |
| Epysqli Interchangeable eculizumab-aagh · BLA 761340 |
Soliris eculizumab |
Samsung Bioepis Co., Ltd. | 19 Jul 2024 |
| Ahzantive aflibercept-mrbb · BLA 761378 |
Eylea aflibercept |
Formycon AG | 28 Jun 2024 |
| Nypozi filgrastim-txid · BLA 761126 |
Neupogen filgrastim |
Tanvex BioPharma USA, Inc. | 28 Jun 2024 |
| Pyzchiva Interchangeable ustekinumab-ttwe · BLA 761373 |
Stelara ustekinumab |
Samsung Bioepis Co., Ltd. | 28 Jun 2024 |
| Pyzchiva Interchangeable ustekinumab-ttwe · BLA 761425 |
Stelara ustekinumab |
Samsung Bioepis Co., Ltd. | 28 Jun 2024 |
| Bkemv Interchangeable eculizumab-aeeb · BLA 761333 |
Soliris eculizumab |
Amgen Inc. | 28 May 2024 |
| Opuviz Interchangeable aflibercept-yszy · BLA 761350 |
Eylea aflibercept |
Samsung Bioepis Co., Ltd. | 20 May 2024 |
| Yesafili Interchangeable aflibercept-jbvf · BLA 761274 |
Eylea aflibercept |
Biocon Biologics Inc. | 20 May 2024 |
| Hercessi trastuzumab-strf · BLA 761346 |
Herceptin trastuzumab |
Accord BioPharma Inc. | 25 Apr 2024 |
| Selarsdi Interchangeable ustekinumab-aekn · BLA 761343 |
Stelara ustekinumab |
Alvotech USA Inc. | 16 Apr 2024 |
| Simlandi Interchangeable adalimumab-ryvk · BLA 761299 |
Humira adalimumab |
Alvotech USA Inc. | 23 Feb 2024 |
| Udenyca pegfilgrastim-cbqv · BLA 761039 |
Neulasta pegfilgrastim |
Accord BioPharma Inc. | 22 Dec 2023 |
| Wezlana Interchangeable ustekinumab-auub · BLA 761285 |
Stelara ustekinumab |
Amgen Inc. | 31 Oct 2023 |
| Wezlana Interchangeable ustekinumab-auub · BLA 761331 |
Stelara ustekinumab |
Amgen Inc. | 31 Oct 2023 |
| Tofidence tocilizumab-bavi · BLA 761354 |
Actemra tocilizumab |
Biogen MA Inc. | 29 Sep 2023 |
| Tyruko natalizumab-sztn · BLA 761322 |
Tysabri natalizumab |
Sandoz Inc. | 24 Aug 2023 |
| Yuflyma Interchangeable adalimumab-aaty · BLA 761219 |
Humira adalimumab |
CELLTRION, Inc. | 23 May 2023 |
| Idacio adalimumab-aacf · BLA 761255 |
Humira adalimumab |
Fresenius Kabi USA, LLC | 13 Dec 2022 |
| Vegzelma bevacizumab-adcd · BLA 761268 |
Avastin bevacizumab |
CELLTRION, Inc. | 27 Sep 2022 |
| Fylnetra pegfilgrastim-pbbk · BLA 761084 |
Neulasta pegfilgrastim |
Kashiv BioSciences, LLC | 26 May 2022 |
| Alymsys bevacizumab-maly · BLA 761231 |
Avastin bevacizumab |
Amneal Pharmaceuticals LLC | 13 Apr 2022 |
| Releuko filgrastim-ayow · BLA 761082 |
Neupogen filgrastim |
Kashiv BioSciences, LLC | 25 Feb 2022 |
| Rezvoglar Interchangeable insulin glargine-aglr · BLA 761215 |
Lantus insulin glargine |
Eli Lilly and Company | 17 Dec 2021 |
| Yusimry adalimumab-aqvh · BLA 761216 |
Humira adalimumab |
Emerge Bioscience Pte. Ltd. | 17 Dec 2021 |
| Byooviz Interchangeable ranibizumab-nuna · BLA 761202 |
Lucentis ranibizumab |
Samsung Bioepis Co., Ltd. | 17 Sep 2021 |
| Semglee Interchangeable insulin glargine-yfgn · BLA 761201 |
Lantus insulin glargine |
Biocon Biologics Inc. | 28 Jul 2021 |
| Riabni rituximab-arrx · BLA 761140 |
Rituxan rituximab |
Amgen Inc. | 17 Dec 2020 |
| Nyvepria pegfilgrastim-apgf · BLA 761111 |
Neulasta pegfilgrastim |
Hospira Inc., a Pfizer Company | 10 Jun 2020 |
| Abrilada Interchangeable adalimumab-afzb · BLA 761118 |
Humira adalimumab |
Pfizer Inc. | 15 Nov 2019 |
| Hadlima Interchangeable adalimumab-bwwd · BLA 761059 |
Humira adalimumab |
Samsung Bioepis Co., Ltd. | 23 Jul 2019 |
| Ruxience rituximab-pvvr · BLA 761103 |
Rituxan rituximab |
Pfizer Ireland Pharmaceuticals Unlimited Company | 23 Jul 2019 |
| Zirabev bevacizumab-bvzr · BLA 761099 |
Avastin bevacizumab |
Pfizer Inc. | 27 Jun 2019 |
| Kanjinti trastuzumab-anns · BLA 761073 |
Herceptin trastuzumab |
Amgen Inc. | 13 Jun 2019 |
| Eticovo Interchangeable etanercept-ykro · BLA 761066 |
Enbrel etanercept |
Samsung Bioepis Co., Ltd. | 25 Apr 2019 Discontinued |
| Ogivri trastuzumab-dkst · BLA 761074 |
Herceptin trastuzumab |
Biocon Biologics Inc. | 17 Apr 2019 |
| Trazimera trastuzumab-qyyp · BLA 761081 |
Herceptin trastuzumab |
Pfizer Ireland Pharmaceuticals Unlimited Company | 11 Mar 2019 |
| Ontruzant trastuzumab-dttb · BLA 761100 |
Herceptin trastuzumab |
Samsung Bioepis Co., Ltd. | 18 Jan 2019 |
| Herzuma trastuzumab-pkrb · BLA 761091 |
Herceptin trastuzumab |
CELLTRION, Inc. | 14 Dec 2018 |
| Truxima Interchangeable rituximab-abbs · BLA 761088 |
Rituxan rituximab |
CELLTRION, Inc. | 28 Nov 2018 |
| Hyrimoz Interchangeable adalimumab-adaz · BLA 761071 |
Humira adalimumab |
Sandoz Inc. | 30 Oct 2018 |
| Nivestym filgrastim-aafi · BLA 761080 |
Neupogen filgrastim |
Hospira Inc., a Pfizer Company | 20 Jul 2018 |
| Retacrit epoetin alfa-epbx · BLA 125545 |
Procrit epoetin alfa |
Hospira Inc., a Pfizer Company | 15 May 2018 |
| Ixifi infliximab-qbtx · BLA 761072 |
Remicade infliximab |
Pfizer Ireland Pharmaceuticals Unlimited Company | 13 Dec 2017 Discontinued |
| Mvasi bevacizumab-awwb · BLA 761028 |
Avastin bevacizumab |
Amgen Inc. | 14 Sep 2017 |
| Cyltezo Interchangeable adalimumab-adbm · BLA 761058 |
Humira adalimumab |
Boehringer Ingelheim Pharmaceuticals, Inc. | 25 Aug 2017 |
| Renflexis infliximab-abda · BLA 761054 |
Remicade infliximab |
Samsung Bioepis Co., Ltd. | 21 Apr 2017 |
| Amjevita Interchangeable adalimumab-atto · BLA 761024 |
Humira adalimumab |
Amgen Inc. | 23 Sep 2016 |
| Erelzi etanercept-szzs · BLA 761042 |
Enbrel etanercept |
Sandoz Inc. | 30 Aug 2016 Discontinued |
| Avsola infliximab-axxq · BLA 761086 |
Remicade infliximab |
Amgen Inc. | |
| Avzivi bevacizumab-tnjn · BLA 761198 |
Avastin bevacizumab |
Bio-Thera Solutions, Ltd. | |
| Cimerli Interchangeable ranibizumab-eqrn · BLA 761165 |
Lucentis ranibizumab |
Sandoz Inc. | |
| Ennumo pegfilgrastim-pccg · BLA 761147 |
Neulasta pegfilgrastim |
Accord BioPharma Inc. | |
| Enzeevu aflibercept-abzv · BLA 761382 |
Eylea aflibercept |
Sandoz Inc. | |
| Eydenzelt aflibercept-boav · BLA 761377 |
Eylea aflibercept |
CELLTRION, Inc. | |
| Fulphila pegfilgrastim-jmdb · BLA 761075 |
Neulasta pegfilgrastim |
Biocon Biologics Inc. | |
| Hulio Interchangeable adalimumab-fkjp · BLA 761154 |
Humira adalimumab |
Biocon Biologics Inc. | |
| Inflectra infliximab-dyyb · BLA 125544 |
Remicade infliximab |
CELLTRION, Inc. | |
| Jobevne bevacizumab-nwgd · BLA 761175 |
Avastin bevacizumab |
Biocon Biologics Inc. | |
| Jubbonti Interchangeable denosumab-bbdz · BLA 761362 |
Prolia denosumab |
Sandoz Inc. | |
| Omlyclo Interchangeable omalizumab-igec · BLA 761399 |
Xolair omalizumab |
CELLTRION, Inc. | |
| Ranluspec Interchangeable ranibizumab-hkdz · BLA 761480 |
Lucentis ranibizumab |
Lupin Limited (Biotech Division) | |
| Stimufend pegfilgrastim-fpgk · BLA 761173 |
Neulasta pegfilgrastim |
Fresenius Kabi USA, LLC | |
| Tyenne tocilizumab-aazg · BLA 761275 |
Actemra tocilizumab |
Fresenius Kabi USA, LLC | |
| Zarxio filgrastim-sndz · BLA 125553 |
Neupogen filgrastim |
Sandoz Inc. | |
| Ziextenzo pegfilgrastim-bmez · BLA 761045 |
Neulasta pegfilgrastim |
Sandoz Inc. |
Jubbonti , interchangeable · Ospomyv 2025, interchangeable · Osenvelt 2025, interchangeable · Bomyntra 2025, interchangeable · Bildyos 2025, interchangeable · Aukelso 2025, interchangeable · Enoby 2025, interchangeable · Jubereq 2025, interchangeable · Boncresa 2025, interchangeable · Oziltus 2025, interchangeable · Ponlimsi 2026, interchangeable
23 clinical trials →Hulio , interchangeable · Amjevita 2016, interchangeable · Cyltezo 2017, interchangeable · Hyrimoz 2018, interchangeable · Hadlima 2019, interchangeable · Abrilada 2019, interchangeable · Yusimry 2021 · Idacio 2022 · Yuflyma 2023, interchangeable · Simlandi 2024, interchangeable
35 clinical trials →Wezlana 2023, interchangeable · Wezlana 2023, interchangeable · Selarsdi 2024, interchangeable · Pyzchiva 2024, interchangeable · Pyzchiva 2024, interchangeable · Otulfi 2024, interchangeable · Imuldosa 2024, interchangeable · Yesintek 2024, interchangeable · Steqeyma 2024, interchangeable · Starjemza 2025, interchangeable
25 clinical trials →Ennumo · Fulphila · Stimufend · Ziextenzo · Nyvepria 2020 · Fylnetra 2022 · Udenyca 2023 · Armlupeg 2025
18 clinical trials →Enzeevu · Eydenzelt · Opuviz 2024, interchangeable · Yesafili 2024, interchangeable · Ahzantive 2024 · Pavblu 2024
42 clinical trials →Avzivi · Jobevne · Mvasi 2017 · Zirabev 2019 · Alymsys 2022 · Vegzelma 2022
400 clinical trials →Herzuma 2018 · Ontruzant 2019 · Trazimera 2019 · Ogivri 2019 · Kanjinti 2019 · Hercessi 2024
128 clinical trials →Zarxio · Nivestym 2018 · Releuko 2022 · Nypozi 2024 · Filkri 2026
14 clinical trials →Tyenne · Tofidence 2023 · Avtozma 2025, interchangeable · Avtozma 2025, interchangeable · Tyenne 2025
71 clinical trials →Avsola · Inflectra · Renflexis 2017 · Ixifi 2017
39 clinical trials →Cimerli , interchangeable · Ranluspec , interchangeable · Byooviz 2021, interchangeable · Nufymco 2025, interchangeable
13 clinical trials →Truxima 2018, interchangeable · Ruxience 2019 · Riabni 2020 · Zimrixby 2026
239 clinical trials →Merilog 2025 · Kirsty 2025, interchangeable · Garzulys 2026
3 clinical trials →Semglee 2021, interchangeable · Rezvoglar 2021, interchangeable · Langlara 2026, interchangeable
2 clinical trials →Bkemv 2024, interchangeable · Epysqli 2024, interchangeable
12 clinical trials →Erelzi 2016 · Eticovo 2019, interchangeable
11 clinical trials →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.
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 27 Sep 2026.