How many biosimilars have been approved in the United States?
Medically reviewed by Judith Stewart, BPharm. Last updated on Sep 21, 2021.
What are the biosimilars for Avastin, Enbrel, Epogen, Herceptin, Humira, Lantus, Lucentis, Neulasta, Neupogen, Remicade, and Rituxan? List of all biosimilars approved in the United States.
Official Answer
by Drugs.comThe number of biosimilars currently approved by the FDA is thirty-one.
The most recent biosimilar approval was Byooviz (ranibizumab-nuna) on September 17, 2021.
Byooviz is the first biosimilar to Lucentis.
What is a biosimilar?
According the to FDA, biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
More information: What Are Biosimilars? Top Facts You May Not Know
Avastin (bevacizumab) Biosimilars
Enbrel (etanercept) Biosimilars
Epogen / Procrit (epoetin alfa) Biosimilars
- Retacrit (epoetin alfa-epbx)
Herceptin (trastuzumab) Biosimilars
- Ogivri (trastuzumab-dkst)
- Herzuma (trastuzumab-pkrb)
- Ontruzant (trastuzumab-dttb)
- Trazimera (trastuzumab-qyyp)
- Kanjinti (trastuzumab-anns)
Humira (adalimumab) Biosimilars
- Amjevita (adalimumab-atto)
- Cyltezo (adalimumab-adbm)
- Hyrimoz (adalimumab-adaz)
- Hadlima (adalimumab-bwwd)
- Abrilada (adalimumab-afzb)
- Hulio (adalimumab-fkjp)
Lantus (insulin glargine) Biosimilars
- Semglee (insulin glargine-yfgn)
Lucentis (ranibizumab) Biosimilars
- Byooviz (ranibizumab-nuna)
Neulasta (pegfilgrastim) Biosimilars
- Fulphila (pegfilgrastim-jmdb)
- Udenyca (pegfilgrastim-cbqv)
- Ziextenzo (pegfilgrastim-bmez)
- Nyvepria (pegfilgrastim-apgf)
Neupogen (filgrastim) Biosimilars
Remicade (infliximab) Biosimilars
- Inflectra (infliximab-dyyb)
- Renflexis (infliximab-abda)
- Ixifi (infliximab-qbtx)
- Avsola (infliximab-axxq)
Rituxan (rituximab) Biosimilars
| Biosimilar | Reference Product | Company | FDA Approval | |
|---|---|---|---|---|
| 31 |
Byooviz (ranibizumab-nuna) |
Lucentis | Samsung Bioepis Co., Ltd. | September 17, 2021 |
| 30 |
Semglee (insulin glargine-yfgn) |
Lantus | Mylan Pharmaceuticals Inc. | July 28, 2021 |
| 29 |
Riabni (rituximab-arrx) |
Rituxan | Amgen Inc. | December 17, 2020 |
| 28 |
Hulio (adalimumab-fkjp) |
Humira | Mylan Pharmaceuticals Inc. | July 6, 2020 |
| 27 |
Nyvepria (pegfilgrastim-apgf) |
Neulasta | Pfizer Inc. | June 10, 2020 |
| 26 |
Avsola (infliximab-axxq) |
Remicade | Amgen Inc. | December 6, 2019 |
| 25 |
Abrilada (adalimumab-afzb) |
Humira | Pfizer Inc. | November 15, 2019 |
| 24 |
Ziextenzo (pegfilgrastim-bmez) |
Neulasta | Sandoz Inc. | November 4, 2019 |
| 23 |
Hadlima (adalimumab-bwwd) |
Humira | Samsung Bioepis Co., Ltd. | July 23, 2019 |
| 22 |
Ruxience (rituximab-pvvr) |
Rituxan | Pfizer Inc. | July 23, 2019 |
| 21 |
Zirabev (bevacizumab-bvzr) |
Avastin | Pfizer Inc. | June 27, 2019 |
| 20 |
Kanjinti (trastuzumab-anns) |
Herceptin | Amgen Inc. | June 13, 2019 |
| 19 |
Eticovo (etanercept-ykro) |
Enbrel | Samsung Bioepis Co., Ltd. | April 25, 2019 |
| 18 |
Trazimera (trastuzumab-qyyp) |
Herceptin | Pfizer Inc. | March 11, 2019 |
| 17 |
Ontruzant (trastuzumab-dttb) |
Herceptin | Samsung Bioepis Co., Ltd. | January 18, 2019 |
| 16 |
Herzuma (trastuzumab-pkrb) |
Herceptin | Celltrion, Inc. | December 14, 2018 |
| 15 |
Truxima (rituximab-abbs) |
Rituxan | Celltrion, Inc. | November 28, 2018 |
| 14 |
Udenyca (pegfilgrastim-cbqv) |
Neulasta | Coherus BioSciences, Inc. | November 2, 2018 |
| 13 |
Hyrimoz (adalimumab-adaz) |
Humira | Sandoz Inc. | October 30, 2018 |
| 12 |
Nivestym (filgrastim-aafi) |
Neupogen | Pfizer Inc. | July 20, 2018 |
| 11 |
Fulphila (pegfilgrastim-jmdb) |
Neulasta | Mylan N.V. | June 4, 2018 |
| 10 |
Retacrit (epoetin alfa-epbx) |
Epogen / Procrit | Hospira Inc. | May 15, 2018 |
| 9 |
Ixifi (infliximab-qbtx) |
Remicade | Pfizer Inc. | December 13, 2017 |
| 8 |
Ogivri (trastuzumab-dkst) |
Herceptin | Mylan GmbH | December 1, 2017 |
| 7 |
Mvasi (bevacizumab-awwb) |
Avastin | Amgen Inc. | September 14, 2017 |
| 6 |
Cyltezo (adalimumab-adbm) |
Humira | Boehringer Ingelheim Pharmaceuticals, Inc. | August 25, 2017 |
| 5 |
Renflexis (infliximab-abda) |
Remicade | Samsung Bioepis Co., Ltd. | April 21, 2017 |
| 4 |
Amjevita (adalimumab-atto) |
Humira | Amgen Inc. | September 23, 2016 |
| 3 |
Erelzi (etanercept-szzs) |
Enbrel | Sandoz Inc. | August 30, 2016 |
| 2 |
Inflectra (infliximab-dyyb) |
Remicade | Celltrion, Inc. | April 5, 2016 |
| 1 |
Zarxio (filgrastim-sndz) |
Neupogen | Sandoz Inc. | March 6, 2015 |
Related Medical Questions
- Does Humira cause weight gain or weight loss?
- What happens when you stop taking Humira?
- How long does it take for Humira to work?
- How much does Humira cost without insurance?
- How long can you stay on Humira?
- How long can Humira be out of the fridge?
- Can you drink alcohol while taking Humira?
- What are the new drugs for the treatment of rheumatoid arthritis (RA)?
- What are the new drugs for the treatment of plaque psoriasis?
- Can you take Humira with antibiotics?
- Skyrizi vs Humira for plaque psoriasis - How do they compare?
- Cosentyx vs Humira: How do they compare?
- What is the difference between Amjevita and Humira?
- What is the difference between Cyltezo and Humira?
Related Support Groups
- Humira (57 questions, 349 members)
- Lantus (43 questions, 110 members)
- Adalimumab (10 questions, 10 members)
- Lucentis (2 questions, 16 members)
- Byooviz (1 questions, 0 members)
- Semglee (1 questions, 3 members)
- Enbrel (20 questions, 201 members)
- Remicade (20 questions, 180 members)
- Neulasta (17 questions, 26 members)
- Rituxan (15 questions, 93 members)
- Pegfilgrastim (13 questions, 4 members)
- Herceptin (12 questions, 28 members)
- Trastuzumab (9 questions, 4 members)
- Etanercept (8 questions, 8 members)
- Rituximab (8 questions, 48 members)
- Infliximab (7 questions, 16 members)
- Udenyca (5 questions, 4 members)
- Fulphila (5 questions, 3 members)
- Amjevita (4 questions, 3 members)
- Renflexis (4 questions, 3 members)
- Inflectra (4 questions, 7 members)
- Ixifi (4 questions, 3 members)
- Cyltezo (4 questions, 3 members)
- Erelzi (4 questions, 3 members)
- Hyrimoz (3 questions, 4 members)
- Hulio (3 questions, 3 members)
- Retacrit (3 questions, 3 members)
- Avsola (3 questions, 3 members)
- Avastin (3 questions, 43 members)
- Eticovo (3 questions, 3 members)
- Herzuma (2 questions, 3 members)
- Mvasi (2 questions, 3 members)
- Neupogen (2 questions, 15 members)
- Epogen (2 questions, 10 members)
- Ogivri (2 questions, 3 members)
- Procrit (2 questions, 14 members)
- Truxima (2 questions, 3 members)
- Filgrastim (2 questions, 5 members)
- Nivestym (2 questions, 3 members)
- Bevacizumab (2 questions, 7 members)
- Epoetin Alfa (1 questions, 3 members)
- Zirabev (1 questions, 3 members)
- Zarxio (1 questions, 5 members)
- Ontruzant (1 questions, 3 members)
- Riabni (1 questions, 3 members)
- Nyvepria (1 questions, 3 members)
- Ziextenzo (1 questions, 3 members)
- Trazimera (1 questions, 3 members)
- Abrilada (1 questions, 3 members)