Biosimilars in United States
Biosimilars licensed by FDA under section 351(k), with interchangeability status, BLA numbers and the month of licensure from the Purple Book.
Regulator: US Food and Drug Administration
FDAproducts approved89
FDAmolecules with a biosimilar21
By molecule
Products approved per molecule.
Denosumab19Adalimumab10Pegfilgrastim8Ustekinumab8Aflibercept6Bevacizumab6Trastuzumab6Filgrastim5Infliximab4Ranibizumab4Rituximab4Insulin aspart3Insulin glargine3Tocilizumab3Eculizumab2Etanercept2Epoetin alfa and zeta1Golimumab1Natalizumab1Omalizumab1Pertuzumab1
Every record
| Molecule | Brand | Developer | Holder or applicant | Approved | Application or permission | Status |
|---|---|---|---|---|---|---|
| Adalimumab | Amjevita | Amgen | Amgen Inc. | Sep 2016 | 761024 | Approved |
| Adalimumab | Cyltezo | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals, Inc. | Aug 2017 | 761058 | Approved |
| Adalimumab | Hyrimoz | Sandoz | Sandoz Inc. | Oct 2018 | 761071 | Approved |
| Adalimumab | Hadlima | Samsung Bioepis | Samsung Bioepis Co., Ltd. | Jul 2019 | 761059 | Approved |
| Adalimumab | Abrilada | Pfizer | Pfizer Inc. | Nov 2019 | 761118 | Approved |
| Adalimumab | Hulio | Fujifilm Kyowa Kirin Biologics | Biocon Biologics Inc. | Jul 2020 | 761154 | Approved |
| Adalimumab | Yusimry | Coherus BioSciences | Emerge Bioscience Pte. Ltd. | Dec 2021 | 761216 | Approved |
| Adalimumab | Idacio | Fresenius Kabi | Fresenius Kabi USA, LLC | Dec 2022 | 761255 | Approved |
| Adalimumab | Yuflyma | Celltrion | CELLTRION, Inc. | May 2023 | 761219 | Approved |
| Adalimumab | Simlandi | Alvotech | Alvotech USA Inc. | Feb 2024 | 761299 | Approved |
| Aflibercept | Yesafili | Biocon Biologics | Biocon Biologics Inc. | May 2024 | 761274 | Approved |
| Aflibercept | Opuviz | Samsung Bioepis | Samsung Bioepis Co., Ltd. | May 2024 | 761350 | Approved |
| Aflibercept | Ahzantive | Formycon | Formycon AG | Jun 2024 | 761378 | Approved |
| Aflibercept | Enzeevu | Sandoz | Sandoz Inc. | Aug 2024 | 761382 | Approved |
| Aflibercept | Pavblu | Amgen | Amgen Inc. | Aug 2024 | 761298 | Approved |
| Aflibercept | Eydenzelt | Celltrion | CELLTRION, Inc. | Oct 2025 | 761377 | Approved |
| Bevacizumab | Mvasi | Amgen | Amgen Inc. | Sep 2017 | 761028 | Approved |
| Bevacizumab | Zirabev | Pfizer | Pfizer Inc. | Jun 2019 | 761099 | Approved |
| Bevacizumab | Alymsys | mAbxience | Amneal Pharmaceuticals LLC | Apr 2022 | 761231 | Approved |
| Bevacizumab | Vegzelma | Celltrion | CELLTRION, Inc. | Sep 2022 | 761268 | Approved |
| Bevacizumab | Avzivi | Bio-Thera Solutions | Bio-Thera Solutions, Ltd. | Dec 2023 | 761198 | Approved |
| Bevacizumab | Jobevne | Biocon Biologics | Biocon Biologics Inc. | Apr 2025 | 761175 | Approved |
| Denosumab | Jubbonti | Sandoz | Sandoz Inc. | Mar 2024 | 761362 | Approved |
| Denosumab | Wyost | Sandoz | Sandoz Inc. | Mar 2024 | 761362 | Approved |
| Denosumab | Ospomyv | Samsung Bioepis | Samsung Bioepis Co., Ltd. | Feb 2025 | 761392 | Approved |
| Denosumab | Xbryk | Samsung Bioepis | Samsung Bioepis Co., Ltd. | Feb 2025 | 761392 | Approved |
| Denosumab | Stoboclo | Celltrion | CELLTRION, Inc. | Feb 2025 | 761404 | Approved |
| Denosumab | Osenvelt | Celltrion | CELLTRION, Inc. | Feb 2025 | 761404 | Approved |
| Denosumab | Conexxence | Fresenius Kabi | Fresenius Kabi USA, LLC | Mar 2025 | 761398 | Approved |
| Denosumab | Bomyntra | Fresenius Kabi | Fresenius Kabi USA, LLC | Mar 2025 | 761398 | Approved |
| Denosumab | Bildyos | Shanghai Henlius Biotech | Shanghai Henlius Biotech, Inc. | Aug 2025 | 761444 | Approved |
| Denosumab | Bilprevda | Shanghai Henlius Biotech | Shanghai Henlius Biotech, Inc. | Aug 2025 | 761444 | Approved |
| Denosumab | Bosaya | Biocon Biologics | Biocon Biologics Inc. | Sep 2025 | 761436 | Approved |
| Denosumab | Aukelso | Biocon Biologics | Biocon Biologics Inc. | Sep 2025 | 761436 | Approved |
| Denosumab | Enoby | Gedeon Richter | Hikma Pharmaceuticals USA Inc. | Sep 2025 | 761439 | Approved |
| Denosumab | Xtrenbo | Gedeon Richter | Hikma Pharmaceuticals USA Inc. | Sep 2025 | 761439 | Approved |
| Denosumab | Osvyrti | Intas Pharmaceuticals | Accord BioPharma Inc. | Oct 2025 | 761424 | Approved |
| Denosumab | Jubereq | Intas Pharmaceuticals | Accord BioPharma Inc. | Oct 2025 | 761424 | Approved |
| Denosumab | Boncresa | mAbxience | Amneal Pharmaceuticals LLC | Dec 2025 | 761456 | Approved |
| Denosumab | Oziltus | mAbxience | Amneal Pharmaceuticals LLC | Dec 2025 | 761457 | Approved |
| Denosumab | Ponlimsi | Teva | Teva Pharmaceuticals, Inc. | Mar 2026 | 761385 | Approved |
| Eculizumab | Bkemv | Amgen | Amgen Inc. | May 2024 | 761333 | Approved |
| Eculizumab | Epysqli | Samsung Bioepis | Samsung Bioepis Co., Ltd. | Jul 2024 | 761340 | Approved |
| Epoetin alfa and zeta | Retacrit | Norbitec | Hospira Inc., a Pfizer Company | May 2018 | 125545 | Approved |
| Etanercept | Erelzi | Sandoz | Sandoz Inc. | Aug 2016 | 761042 | Approved |
| Etanercept | Eticovo | Samsung Bioepis | Samsung Bioepis Co., Ltd. | Apr 2019 | 761066 | Approved |
| Filgrastim | Zarxio | Sandoz | Sandoz Inc. | Mar 2015 | 125553 | Approved |
| Filgrastim | Nivestym | Pfizer | Hospira Inc., a Pfizer Company | Jul 2018 | 761080 | Approved |
| Filgrastim | Releuko | Kashiv BioSciences | Kashiv BioSciences, LLC | Feb 2022 | 761082 | Approved |
| Filgrastim | Nypozi | Tanvex BioPharma | Tanvex BioPharma USA, Inc. | Jun 2024 | 761126 | Approved |
| Filgrastim | Filkri | Intas Pharmaceuticals | Accord BioPharma Inc. | Jan 2026 | 761027 | Approved |
| Golimumab | Immgolis | Not stated in the Purple Book | Accord BioPharma Inc. | May 2026 | 761452 | Approved |
| Infliximab | Inflectra | Celltrion | CELLTRION, Inc. | Apr 2016 | 125544 | Approved |
| Infliximab | Renflexis | Samsung Bioepis | Samsung Bioepis Co., Ltd. | Apr 2017 | 761054 | Approved |
| Infliximab | Ixifi | Pfizer | Pfizer Ireland Pharmaceuticals Unlimited Company | Dec 2017 | 761072 | Approved |
| Infliximab | Avsola | Amgen | Amgen Inc. | Dec 2019 | 761086 | Approved |
| Insulin aspart | Merilog | Sanofi | Sanofi-Aventis U.S. LLC | Feb 2025 | 761325 | Approved |
| Insulin aspart | Kirsty | Biocon Biologics | Biocon Biologics Inc. | Jul 2025 | 761188 | Approved |
| Insulin aspart | Garzulys | Not stated in the Purple Book | Emerge Bioscience Pte. Ltd. | Jul 2026 | 761497 | Approved |
| Insulin glargine | Semglee | Biocon Biologics | Biocon Biologics Inc. | Jul 2021 | 761201 | Approved |
| Insulin glargine | Rezvoglar | Eli Lilly | Eli Lilly and Company | Dec 2021 | 761215 | Approved |
| Insulin glargine | Langlara | Sunshine Lake Pharma | Sunshine Lake Pharma Co., Ltd. | Apr 2026 | 761412 | Approved |
| Natalizumab | Tyruko | Polpharma Biologics | Sandoz Inc. | Aug 2023 | 761322 | Approved |
| Omalizumab | Omlyclo | Celltrion | CELLTRION, Inc. | Mar 2025 | 761399 | Approved |
| Pegfilgrastim | Fulphila | Biocon Biologics | Biocon Biologics Inc. | Jun 2018 | 761075 | Approved |
| Pegfilgrastim | Udenyca | Coherus BioSciences | Accord BioPharma Inc. | Nov 2018 | 761039 | Approved |
| Pegfilgrastim | Ziextenzo | Sandoz | Sandoz Inc. | Nov 2019 | 761045 | Approved |
| Pegfilgrastim | Nyvepria | Pfizer | Hospira Inc., a Pfizer Company | Jun 2020 | 761111 | Approved |
| Pegfilgrastim | Fylnetra | Kashiv BioSciences | Kashiv BioSciences, LLC | May 2022 | 761084 | Approved |
| Pegfilgrastim | Stimufend | Fresenius Kabi | Fresenius Kabi USA, LLC | Sep 2022 | 761173 | Approved |
| Pegfilgrastim | Armlupeg | Lupin | Lupin Limited (Biotech Division) | Nov 2025 | 761212 | Approved |
| Pegfilgrastim | Ennumo | Intas Pharmaceuticals | Accord BioPharma Inc. | May 2026 | 761147 | Approved |
| Pertuzumab | Poherdy | Shanghai Henlius Biotech | Shanghai Henlius Biotech, Inc. | Nov 2025 | 761450 | Approved |
| Ranibizumab | Byooviz | Samsung Bioepis | Samsung Bioepis Co., Ltd. | Sep 2021 | 761202 | Approved |
| Ranibizumab | Cimerli | Bioeq | Sandoz Inc. | Aug 2022 | 761165 | Approved |
| Ranibizumab | Nufymco | Zydus Lifesciences | Zydus Lifesciences Global FZE | Dec 2025 | 761473 | Approved |
| Ranibizumab | Ranluspec | Lupin | Lupin Limited (Biotech Division) | Jun 2026 | 761480 | Approved |
| Rituximab | Truxima | Celltrion | CELLTRION, Inc. | Nov 2018 | 761088 | Approved |
| Rituximab | Ruxience | Pfizer | Pfizer Ireland Pharmaceuticals Unlimited Company | Jul 2019 | 761103 | Approved |
| Rituximab | Riabni | Amgen | Amgen Inc. | Dec 2020 | 761140 | Approved |
| Rituximab | Zimrixby | Dr. Reddy's Laboratories | Dr. Reddy's Laboratories SA | Jul 2026 | 761376 | Approved |
| Tocilizumab | Tofidence | Bio-Thera Solutions | Biogen MA Inc. | Sep 2023 | 761354 | Approved |
| Tocilizumab | Tyenne | Fresenius Kabi | Fresenius Kabi USA, LLC | Mar 2024 | 761275 | Approved |
| Tocilizumab | Avtozma | Celltrion | CELLTRION, Inc. | Jan 2025 | 761420 | Approved |
| Trastuzumab | Ogivri | Biocon Biologics | Biocon Biologics Inc. | Dec 2017 | 761074 | Approved |
| Trastuzumab | Herzuma | Celltrion | CELLTRION, Inc. | Dec 2018 | 761091 | Approved |
| Trastuzumab | Ontruzant | Samsung Bioepis | Samsung Bioepis Co., Ltd. | Jan 2019 | 761100 | Approved |
| Trastuzumab | Trazimera | Pfizer | Pfizer Ireland Pharmaceuticals Unlimited Company | Mar 2019 | 761081 | Approved |
| Trastuzumab | Kanjinti | Amgen | Amgen Inc. | Jun 2019 | 761073 | Approved |
| Trastuzumab | Hercessi | Shanghai Henlius Biotech | Accord BioPharma Inc. | Apr 2024 | 761346 | Approved |
| Ustekinumab | Wezlana | Amgen | Amgen Inc. | Oct 2023 | 761285 | Approved |
| Ustekinumab | Selarsdi | Alvotech | Alvotech USA Inc. | Apr 2024 | 761343 | Approved |
| Ustekinumab | Pyzchiva | Samsung Bioepis | Samsung Bioepis Co., Ltd. | Jun 2024 | 761373 | Approved |
| Ustekinumab | Otulfi | Formycon | Fresenius Kabi USA, LLC | Sep 2024 | 761379 | Approved |
| Ustekinumab | Imuldosa | Dong-A ST | Accord BioPharma Inc. | Oct 2024 | 761364 | Approved |
| Ustekinumab | Yesintek | Biocon Biologics | Biocon Biologics Inc. | Nov 2024 | 761406 | Approved |
| Ustekinumab | Steqeyma | Celltrion | CELLTRION, Inc. | Dec 2024 | 761338 | Approved |
| Ustekinumab | Starjemza | Bio-Thera Solutions | Bio-Thera Solutions, Ltd. | May 2025 | 761419 | Approved |
Records checked against FDA's files, Sep 2026.
How FDA assesses a biosimilar
| Legal pathway | Section 351(k) of the Public Health Service Act (BPCIA 2009) |
|---|---|
| Reference product | US-licensed reference; a non-US comparator may be used with analytical and PK bridging |
| Comparative clinical study | Draft guidance (October 2025): comparative analytical assessment plus a PK similarity study and immunogenicity assessment; a comparative efficacy study is generally not needed |
| Interchangeability | A separate designation permitting pharmacy-level substitution; switching studies generally not required under the June 2024 draft |
| Naming | INN plus a four-letter suffix |
Sources: FDA draft guidance on comparative efficacy studies (October 2025) and interchangeability (June 2024); EMA reflection paper EMA/CHMP/BMWP/60916/2025 (March 2026) and EMA/HMA statement on interchangeability (September 2022); CDSCO Guidelines on Similar Biologics 2016 and 2025 draft (S009, S010); EDE directory (S018); MHLW/PMDA biosimilar guideline and notifications (S021); Health Canada guidance on biosimilar biologic drugs.
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Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)
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