How many biosimilars have been approved in the United States?

The are currently 40 approved biosimilars approved by the FDA (Food and Drug Administration). The most recent biosimilar approval was Idacio (adalimumab-aacf) on December 13, 2022.

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)

Biosimilars by approval date

1. Idacio (adalimumab-aacf) - December 13, 2022
2. Vegzelma (bevacizumab-adcd) - September 27, 2022
3. Stimufend (pegfilgrastim-fpgk) - September 1, 2022
4. Cimerli (ranibizumab-eqrn) - August 2, 2022
5. Fylnetra (pegfilgrastim-pbbk) - May 26, 2022
6. Alymsys (bevacizumab-maly) - April 13, 2022
7. Releuko (filgrastim-ayow) - February 25, 2022
8. Yusimry (adalimumab-aqvh) - December 17, 2021
9. Rezvoglar (insulin glargine-aglr) - December 17, 2021
10. Byooviz (ranibizumab-nuna) - September 17, 2021
11. Semglee (insulin glargine-yfgn) - July 28, 2021
12. Riabni (rituximab-arrx) - December 17, 2020
13. Hulio (adalimumab-fkjp) - July 6, 2020
14. Nyvepria (pegfilgrastim-apgf) - June 10, 2020
15. Avsola (infliximab-axxq) - December 6, 2019
16. Abrilada (adalimumab-afzb) - November 15, 2019
17. Ziextenzo (pegfilgrastim-bmez) - November 4, 2019
18. Hadlima (adalimumab-bwwd) - July 23, 2019
19. Ruxience (rituximab-pvvr) - July 23, 2019
20. Zirabev (bevacizumab-bvzr) - June 27, 2019
21. Kanjinti (trastuzumab-anns) - June 13, 2019
22. Eticovo (etanercept-ykro) - April 25, 2019
23. Trazimera (trastuzumab-qyyp) - March 11, 2019
24. Ontruzant (trastuzumab-dttb) - January 18, 2019
25. Herzuma (trastuzumab-pkrb) - December 14, 2018
26. Truxima (rituximab-abbs) - November 28, 2018
27. Udenyca (pegfilgrastim-cbqv) - November 2, 2018
28. Hyrimoz (adalimumab-adaz) - October 30, 2018
29. Nivestym (filgrastim-aafi) - July 20, 2018
30. Fulphila (pegfilgrastim-jmdb) - June 4, 2018
31. Retacrit (epoetin alfa-epbx) - May 15, 2018
32. Ixifi (infliximab-qbtx) - December 13, 2017
33. Ogivri (trastuzumab-dkst) - December 1, 2017
34. Mvasi (bevacizumab-awwb) - September 14, 2017
35. Cyltezo (adalimumab-adbm) - August 25, 2017
36. Renflexis (infliximab-abda) - April 21, 2017
37. Amjevita (adalimumab-atto) - September 23, 2016
38. Erelzi (etanercept-szzs) - August 30, 2016
39. Inflectra (infliximab-dyyb) - April 5, 2016
40. Zarxio (filgrastim-sndz) - March 6, 2015