Biosimilar Product Information
The Food and Drug Administration approves biosimilar products and provides the scientific and regulatory advice needed to bring safe and effective biosimilars to market. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.
FDA-Approved Biosimilar Products
| Biosimilar Name | Approval Date | Reference Product | More Information |
|---|---|---|---|
| Fylnetra (pegfilgrastim-pbbk) | May 2022 | Neulasta (pegfilgrastim) | Fylnetra Information |
| Alymsys (bevacizumab-maly) | April 2022 | Avastin (bevacizumab) | Alymsys Information |
| Releuko (filgrastim-ayow) | February 2022 | Neupogen (filgrastim) | |
| Yusimry (adalimumab-aqvh) | December 2021 | Humira (adalimumab) | Yusimry Information |
| Rezvoglar (insulin glargine-aglr) |
December 2021 | Lantus (insulin glargine) | Rezvoglar |
| Byooviz (ranibizumab-nuna) |
September 2021 | Lucentis (ranibizumab) | Byooviz Information Press Release: FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions |
| Semglee (Insulin glargine-yfgn) |
July 2021 | Lantus (Insulin glargine) | Semglee Information Press Release: FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes |
| Riabni (rituximab-arrx) |
December 2020 | Rituxan (rituximab) | Riabni Information |
| Hulio (adalimumab-fkjp) |
July 2020 | Humira (adalimumab) | Hulio Information |
| Nyvepria (pegfilgrastim-apgf) |
June 2020 | Neulasta (pegfilgrastim) | Nyvepria Information |
| Avsola (infliximab-axxq) |
December 2019 | Remicade (infliximab) | Avsola Information |
| Abrilada (adalimumab-afzb) |
November 2019 | Humira (adalimumab) | Abrilada Information |
| Ziextenzo (pegfilgrastim-bmez) |
November 2019 | Neulasta (pegfilgrastim) | Ziextenzo Information |
| Hadlima (adalimumab-bwwd) |
July 2019 | Humira (adalimumab) | Hadlima Information |
| Ruxience (rituximab-pvvr) |
July 2019 | Rituxan (rituximab) | Ruxience Information |
| Zirabev (bevacizumab-bvzr) |
|||
| Alymsys (bevacizumab-maly) | April 2022 | Avastin (bevacizumab) | Alymsys Information |
| Releuko (filgrastim-ayow) | February 2022 | Neupogen (filgrastim) | |
| Yusimry (adalimumab-aqvh) | December 2021 | Humira (adalimumab) | Yusimry Information |
| Rezvoglar (insulin glargine-aglr) |
December 2021 | Lantus (insulin glargine) | Rezvoglar |
| Byooviz (ranibizumab-nuna) |
September 2021 | Lucentis (ranibizumab) | Byooviz Information Press Release: FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions |
| Semglee (Insulin glargine-yfgn) |
July 2021 | Lantus (Insulin glargine) | Semglee Information Press Release: FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes |
| Riabni (rituximab-arrx) |
December 2020 | Rituxan (rituximab) | Riabni Information |
| Hulio (adalimumab-fkjp) |
July 2020 | Humira (adalimumab) | Hulio Information |
| Nyvepria (pegfilgrastim-apgf) |
June 2020 | Neulasta (pegfilgrastim) | Nyvepria Information |
| Avsola (infliximab-axxq) |
December 2019 | Remicade (infliximab) | Avsola Information |
| Abrilada (adalimumab-afzb) |
November 2019 | Humira (adalimumab) | Abrilada Information |
| Ziextenzo (pegfilgrastim-bmez) |
November 2019 | Neulasta (pegfilgrastim) | Ziextenzo Information |
| Hadlima (adalimumab-bwwd) |
July 2019 | Humira (adalimumab) | Hadlima Information |
| Ruxience (rituximab-pvvr) |
July 2019 | Rituxan (rituximab) | Ruxience Information |
| Zirabev | Avastin (bevacizumab) | Mvasi information Press Release: FDA approves first biosimilar for the treatment of cancer |
|
| Cyltezo (Adalimumab-adbm) |
August 2017 | Humira (adalimumab) | Cyltezo information |
| Renflexis (Infliximab-abda) | May 2017 | Remicade (infliximab) | Renflexis information |
| Amjevita (Adalimumab -atto) |
September 2016 | Humira (adalimumab) | Amjevita information Press Release: FDA approves Amjevita |
| Erelzi (Etanercept-szzs) |
August 2016 | Enbrel (etanercept) | Erelzi information Press Release: FDA approves Erelzi |
| Inflectra (Infliximab-dyyb) |
April 2016 | Remicade (infliximab) | Inflectra information Press Release: FDA approves Inflectra |
| Zarxio (Filgrastim-sndz) |
March 2015 | Neupogen (filgrastim) | Zarxio information Press Release: FDA approves first biosimilar |
Learn More
The "Purple Book" is available as a searchable, online database that contains information about all FDA-licensed biological products regulated by the Center for Drug Evaluation and Research (CDER), including biosimilar and interchangeable biological products, and a list containing information about all FDA-licensed biological products regulated by the Center for Biologics Evaluation.