The marketing of many biosimilars has met resistance in the U.S. recently as FDA sent CRLs for them. According to statistics, FDA has approved 9 biosimilars since March 2015. I’d like to analyze the market data of the marketed biosimilars here.
I. The marketed biosimilars in the U.S.
There have been 9 biosimilars marketed in the U.S. so far, including 1 biosimilar of Filgrastim, 3 biosimilars of Infliximab, 1 biosimilar of Etanercept, 2 biosimilars of Adalimumab, 1 biosimilar of Bevacizumab, and 1 biosimilar of trastuzumab, with the information as follows:
|
Biosimilar |
Company |
Original drug |
Approval date |
Marketing situation |
|---|---|---|---|---|
|
Zarxio (filgrastim-sndz) |
Sandoz |
Neupogen |
March 6, 2015 |
Marketed in September 2015, pending patent litigation |
|
Inflectra (infliximab-dyyb) |
Celltrion Hospira |
Remicade |
April 5, 2016 |
Marketed in November 2016, pending patent litigation |
|
Erelzi (etanercept-szzs) |
Sandoz |
Enbrel |
August 30, 2016 |
No marketing plan; pending patent litigation |
|
Amjevita (adalimumab-atto) |
Amgen |
Humira |
September 23, 2016 |
To be marketed in January 2023, settled with AbbVie |
|
Renflexis (infliximab-abda) |
Samsung Bioepis |
Remicade |
April 21, 2017 |
Marketed in July 2017, J & J dropped the suit |
|
Cyltezo (adalimumab-adbm) |
Boehringer Ingelheim |
Humira |
August 25, 2017 |
No marketing plan; pending patent litigation |
|
Mvasi (bevacizumab-awwb) |
Amgen/Allergan |
Avastin |
September 14, 2017 |
No marketing plan; pending patent litigation |
|
Ogivri (trastuzumab-dkst) |
Mylan/Biocon |
Herceptin |
December 1, 2017 |
No marketing plan released, patent settlement |
|
Ixifi (infliximab-qbtx) |
Pfizer |
Remicade |
...









(All Rights Reserved)