Medically reviewed by Judith Stewart, BPharm. Last updated on March 12, 2024.
What are the biosimilars for Actemra, Avastin, Enbrel, Epogen, Herceptin, Humira, Lantus, Lucentis, Neulasta, Neupogen, Prolia, Remicade, Rituxan, Stelara, Tysabri, and Xgeva? List of all biosimilars approved in the United States.
Official answer
by Drugs.com
There are currently 49 approved biosimilars approved by the U.S. Food and Drug Administration (FDA). The most recent biosimilar approval was Tyenne (tocilizumab-aazg) on March 5, 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 pharmaco*kinetic 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 |
| Name | Regulatory Designation | Company Name | FDA Approved |
|---|---|---|---|
| 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) | Biosimilar | 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 |
|---|---|---|---|
| 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 |
|---|---|---|---|
| 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 |
Related Questions
- Basaglar and Lantus - What is the difference between them?
- What are biosimilar drugs?
- Toujeo vs Lantus - What's the difference between them?
Biosimilars by approval date - 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
Read next
Soliqua is a combination of insulin glargine plus lixisenatide, and Lantus only contains insulin glargine. Both are once-daily injections that are given under the skin (subcutaneously), but Soliqua can only be used in adults with type 2 diabetes whereas Lantus may be used to treat both type 1 and type 2 diabetes in adults and children over the age of six years. Both are made by Sanofi-Aventis. Continue reading
No, Admelog (insulin lispro) is not the same as NovoLog (insulin aspart). These insulins have different chemical structures but they are both man-made, rapid-acting forms of insulin used to help lower mealtime blood sugar (glucose) levels in patients with diabetes. Continue reading
Both Soliqua and Xultophy combine a long-acting insulin with a GLP-1 agonist: Xultopy brings together Tresiba (insulin degludec) and Victoza (liraglutide), while Soliqua combines Lantus (insulin glargine) with Adlyxin (lixisenatide). When used with diet and exercise for the treatment of type 2 diabetes, these agents can help you control blood sugar, insulin levels, and digestion and may help you lose weight. Continue reading
Related medical questions
- When should I take Lantus?
- Levemir vs Lantus: What's the difference?
- Does Lantus insulin need to be refrigerated?
- How long does Lantus last?
- Can you mix Humalog with Lantus?
- Is Tresiba the same as Lantus?
- How do you use the Lantus pen (Lantus SoloStar)?
- Does Lantus insulin raise or lower your blood sugar?
- Does Lantus cause weight gain?
- Which type of insulin has the longest duration of action?
- How do medications help with diabetes?
- What's the difference between Prolia and Reclast?
- Does Prolia weaken your immune system?
- Does Prolia cause weight gain?
- How do you give a Prolia injection?
- Does Prolia increase bone density?
- Can you drink alcohol while taking Prolia?
- Xgeva vs Prolia. How do they compare?
- How many years should you take Prolia?
- How long will the side effects of Prolia last?
- What medications are available to treat osteoporosis?
- Insights from a Pharmacist about Osteoporosis Treatments
- How can I prevent osteoporosis?
Related support groups
- Lantus(47 questions, 117 members)
- Prolia(39 questions, 213 members)
- Xgeva(9 questions, 31 members)
- Wyost(1 questions, 0 members)
- Tyenne(1 questions, 0 members)
- Jubbonti(1 questions, 0 members)
- Humira(69 questions, 369 members)
- Enbrel(25 questions, 209 members)
- Remicade(23 questions, 185 members)
- Rituxan(20 questions, 103 members)
- Stelara(20 questions, 67 members)
Medical Disclaimer
