What biosimilars have been approved in the United States?
What are the biosimilars for Actemra, Avastin, Enbrel, Epogen, Eylea, Herceptin, Humira, Lantus, Lucentis, Neulasta, Neupogen, Prolia, Remicade, Rituxan, Soliris, Stelara, Tysabri, and Xgeva? List of all biosimilars approved in the United States.
There are currently 57 biosimilars approved by the U.S. Food and Drug Administration (FDA). The most recent biosimilar approvals were Nypozi (filgrastim-txid), Pyzchiva (ustekinumab-ttwe) and Ahzantive (aflibercept-mrbb) on June 28, 2024.
What is a Biosimilar?
According the to FDA, a biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from an existing FDA-approved reference product.
Biological products are a diverse category of products, and include therapeutic proteins (example filgrastim) and monoclonal antibodies (example adalimumab). Biological products are generally large, complex molecules, and inherent variations are normal and expected within the manufacturing process.
A manufacturer developing a biosimilar will need to demonstrate that its product is highly similar to the characteristics of the reference product in terms of purity, chemical identity, and bioactivity. The manufacturer must also demonstrate that its product has no clinically meaningful differences to the reference product in terms of safety, purity, and potency (safety and effectiveness) which is determined though human pharmacokinetic and pharmacodynamic studies, and additional clinical studies if needed.
Biosimilar products can only be dispensed in place of another biological product if the health care provider specifically prescribes the biosimilar product by name.
What is an Interchangeable?
An interchangeable product is a biological product that meets all the requirements for a biosimilar product, but also meets additional requirements outlined by the Biologics Price Competition and Innovation Act.
A manufacturer developing an interchangeable product will need to demonstrate that its product is expected to produce the same clinical result as the reference product in any given patient. If a product is to be administered to a patient more than once, the risk in terms of safety and reduced efficacy of switching back and forth between an interchangeable product and a reference product will need to have been evaluated.
Interchangeable products may be substituted at pharmacy-level without the intervention of the health care provider who prescribed the reference product. A health care provider also can prescribe an interchangeable product just like they would prescribe a biosimilar or a reference product. (Note that pharmacy laws and practices vary from state to state.)
Learn about cost-savings, clinical use, and safety of biosimilars.
Biosimilars by reference product (or by approval date)
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Tyenne (tocilizumab-aazg) |
Biosimilar | Fresenius Kabi USA, LLC | March 5, 2024 |
|
Tofidence (tocilizumab-bavi) |
Biosimilar | Biogen Inc. | September 29, 2023 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Avzivi (bevacizumab-tnjn) |
Biosimilar | Bio-Thera Solutions, Ltd. | December 6, 2023 |
|
Vegzelma (bevacizumab-adcd) |
Biosimilar | Celltrion, Inc. | September 27, 2022 |
|
Alymsys (bevacizumab-maly) |
Biosimilar | Amneal Pharmaceuticals, Inc. | April 13, 2022 |
|
Zirabev (bevacizumab-bvzr) |
Biosimilar | Pfizer Inc. | June 27, 2019 |
|
Mvasi (bevacizumab-awwb) |
Biosimilar | Amgen Inc. | September 14, 2017 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Eticovo (etanercept-ykro) |
Biosimilar | Samsung Bioepis Co., Ltd. | April 25, 2019 |
|
Erelzi (etanercept-szzs) |
Biosimilar | Sandoz Inc. | August 30, 2016 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Retacrit (epoetin alfa-epbx) |
Biosimilar | Hospira Inc. | May 15, 2018 |
|
Ahzantive (aflibercept-mrbb) |
Biosimilar | Formycon AG | June 28, 2024 |
|
Opuviz (aflibercept-yszy) |
Interchangeable | Samsung Bioepis Co., Ltd. | May 20, 2024 |
|
Yesafili (aflibercept-jbvf) |
Interchangeable | Biocon Biologics Inc. | May 20, 2024 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Hercessi (trastuzumab-strf) |
Biosimilar | Accord BioPharma Inc. | April 26, 2024 |
|
Kanjinti (trastuzumab-anns) |
Biosimilar | Amgen Inc. | June 13, 2019 |
|
Trazimera (trastuzumab-qyyp) |
Biosimilar | Pfizer Inc. | March 11, 2019 |
|
Ontruzant (trastuzumab-dttb) |
Biosimilar | Samsung Bioepis Co., Ltd. | January 18, 2019 |
|
Herzuma (trastuzumab-pkrb) |
Biosimilar | Celltrion, Inc. | December 14, 2018 |
|
Ogivri (trastuzumab-dkst) |
Biosimilar | Mylan GmbH | December 1, 2017 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Simlandi (adalimumab-ryvk) |
Interchangeable | Alvotech and Teva Pharmaceutical Industries Ltd. | February 23, 2024 |
|
Yuflyma (adalimumab-aaty) |
Biosimilar | Celltrion, Inc. | May 23, 2023 |
|
Idacio (adalimumab-aacf) |
Biosimilar | Fresenius Kabi USA, LLC | December 13, 2022 |
|
Yusimry (adalimumab-aqvh) |
Biosimilar | Coherus BioSciences, Inc. | December 17, 2021 |
|
Hulio (adalimumab-fkjp) |
Biosimilar | Mylan Pharmaceuticals Inc. | July 6, 2020 |
|
Abrilada (adalimumab-afzb) |
Interchangeable | Pfizer Inc. | November 15, 2019 |
|
Hadlima (adalimumab-bwwd) |
Biosimilar | Samsung Bioepis Co., Ltd. | July 23, 2019 |
|
Hyrimoz (adalimumab-adaz) |
Interchangeable (certain strengths) | Sandoz Inc. | October 30, 2018 |
|
Cyltezo (adalimumab-adbm) |
Interchangeable | Boehringer Ingelheim Pharmaceuticals, Inc. | August 25, 2017 |
|
Amjevita (adalimumab-atto) |
Biosimilar | Amgen Inc. | September 23, 2016 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Rezvoglar (insulin glargine-aglr) |
Interchangeable | Eli Lilly and Company | December 17, 2021 |
|
Semglee (insulin glargine-yfgn) |
Interchangeable | Mylan Pharmaceuticals Inc. | July 28, 2021 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Cimerli (ranibizumab-eqrn) |
Interchangeable | Coherus BioSciences, Inc. | August 2, 2022 |
|
Byooviz (ranibizumab-nuna) |
Interchangeable | Samsung Bioepis Co., Ltd. | September 17, 2021 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Stimufend (pegfilgrastim-fpgk) |
Biosimilar | Fresenius Kabi USA, LLC | September 1, 2022 |
|
Fylnetra (pegfilgrastim-pbbk) |
Biosimilar | Amneal Pharmaceuticals, Inc. | May 26, 2022 |
|
Nyvepria (pegfilgrastim-apgf) |
Biosimilar | Pfizer Inc. | June 10, 2020 |
|
Ziextenzo (pegfilgrastim-bmez) |
Biosimilar | Sandoz Inc. | November 4, 2019 |
|
Udenyca (pegfilgrastim-cbqv) |
Biosimilar | Coherus BioSciences, Inc. | November 2, 2018 |
|
Fulphila (pegfilgrastim-jmdb) |
Biosimilar | Mylan N.V. | June 4, 2018 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Nypozi (filgrastim-txid) |
Biosimilar | Tanvex BioPharma USA, Inc. | June 28, 2024 |
|
Releuko (filgrastim-ayow) |
Biosimilar | Kashiv BioSciences, LLC | February 25, 2022 |
|
Nivestym (filgrastim-aafi) |
Biosimilar | Pfizer Inc. | July 20, 2018 |
|
Zarxio (filgrastim-sndz) |
Biosimilar | Sandoz Inc. | March 6, 2015 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Jubbonti (denosumab-bbdz) |
Interchangeable | Sandoz Inc. | March 5, 2024 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Avsola (infliximab-axxq) |
Biosimilar | Amgen Inc. | December 6, 2019 |
|
Ixifi (infliximab-qbtx) |
Biosimilar | Pfizer Inc. | December 13, 2017 |
|
Renflexis (infliximab-abda) |
Biosimilar | Samsung Bioepis Co., Ltd. | April 21, 2017 |
|
Inflectra (infliximab-dyyb) |
Biosimilar | Celltrion, Inc. | April 5, 2016 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Riabni (rituximab-arrx) |
Biosimilar | Amgen Inc. | December 17, 2020 |
|
Ruxience (rituximab-pvvr) |
Biosimilar | Pfizer Inc. | July 23, 2019 |
|
Truxima (rituximab-abbs) |
Biosimilar | Celltrion, Inc. | November 28, 2018 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Bkemv (eculizumab-aeeb) |
Interchangeable | Amgen Inc. | May 28, 2024 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Pyzchiva (ustekinumab-ttwe) |
Biosimilar (provisionally interchangeable) |
Sandoz and Samsung Bioepis Co., Ltd. | June 28, 2024 |
|
Selarsdi (ustekinumab-aekn) |
Biosimilar | Alvotech and Teva Pharmaceutical Industries Ltd. | April 16, 2024 |
|
Wezlana (ustekinumab-auub) |
Interchangeable | Amgen Inc. | October 31, 2023 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Tyruko (natalizumab-sztn) |
Biosimilar | Sandoz Inc. | August 24, 2023 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
|
Wyost (denosumab-bbdz) |
Interchangeable | Sandoz Inc. | March 5, 2024 |
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Biosimilars by approval date
- Ahzantive (aflibercept-mrbb) - June 28, 2024
- Pyzchiva (ustekinumab-ttwe) - June 28, 2024
- Nypozi (filgrastim-txid) - June 28, 2024
- Bkemv (eculizumab-aeeb) - May 28, 2024
- Yesafili (aflibercept-jbvf) - May 20, 2024
- Opuviz (aflibercept-yszy) - May 20, 2024
- Hercessi (trastuzumab-strf) - April 25, 2024
- Selarsdi (ustekinumab-aekn) - April 16, 2024
- Tyenne (tocilizumab-aazg) - March 5, 2024
- Jubbonti (denosumab-bbdz) - March 5, 2024
- Wyost (denosumab-bbdz) - March 5, 2024
- Simlandi (adalimumab-ryvk) - February 23, 2024
- Avzivi (bevacizumab-tnjn) - December 6, 2023
- Wezlana (ustekinumab-auub) - October 31, 2023
- Tofidence (tocilizumab-bavi) - September 29, 2023
- Tyruko (natalizumab-sztn) - August 24, 2023
- Yuflyma (adalimumab-aaty) - May 23, 2023
- Idacio (adalimumab-aacf) - December 13, 2022
- Vegzelma (bevacizumab-adcd) - September 27, 2022
- Stimufend (pegfilgrastim-fpgk) - September 1, 2022
- Cimerli (ranibizumab-eqrn) - August 2, 2022
- Fylnetra (pegfilgrastim-pbbk) - May 26, 2022
- Alymsys (bevacizumab-maly) - April 13, 2022
- Releuko (filgrastim-ayow) - February 25, 2022
- Yusimry (adalimumab-aqvh) - December 17, 2021
- Rezvoglar (insulin glargine-aglr) - December 17, 2021
- Byooviz (ranibizumab-nuna) - September 17, 2021
- Semglee (insulin glargine-yfgn) - July 28, 2021
- Riabni (rituximab-arrx) - December 17, 2020
- Hulio (adalimumab-fkjp) - July 6, 2020
- Nyvepria (pegfilgrastim-apgf) - June 10, 2020
- Avsola (infliximab-axxq) - December 6, 2019
- Abrilada (adalimumab-afzb) - November 15, 2019
- Ziextenzo (pegfilgrastim-bmez) - November 4, 2019
- Hadlima (adalimumab-bwwd) - July 23, 2019
- Ruxience (rituximab-pvvr) - July 23, 2019
- Zirabev (bevacizumab-bvzr) - June 27, 2019
- Kanjinti (trastuzumab-anns) - June 13, 2019
- Eticovo (etanercept-ykro) - April 25, 2019
- Trazimera (trastuzumab-qyyp) - March 11, 2019
- Ontruzant (trastuzumab-dttb) - January 18, 2019
- Herzuma (trastuzumab-pkrb) - December 14, 2018
- Truxima (rituximab-abbs) - November 28, 2018
- Udenyca (pegfilgrastim-cbqv) - November 2, 2018
- Hyrimoz (adalimumab-adaz) - October 30, 2018
- Nivestym (filgrastim-aafi) - July 20, 2018
- Fulphila (pegfilgrastim-jmdb) - June 4, 2018
- Retacrit (epoetin alfa-epbx) - May 15, 2018
- Ixifi (infliximab-qbtx) - December 13, 2017
- Ogivri (trastuzumab-dkst) - December 1, 2017
- Mvasi (bevacizumab-awwb) - September 14, 2017
- Cyltezo (adalimumab-adbm) - August 25, 2017
- Renflexis (infliximab-abda) - April 21, 2017
- Amjevita (adalimumab-atto) - September 23, 2016
- Erelzi (etanercept-szzs) - August 30, 2016
- Inflectra (infliximab-dyyb) - April 5, 2016
- Zarxio (filgrastim-sndz) - March 6, 2015
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