BIOSIMILAR DRUG STATUS IN THE US: FDA FILING DATES AND ACTIONS |
|||||
Biosimilar |
Manufacturer |
Brand Name & Designation |
Innovator Product |
FDA Filing Date |
Status |
Epoetin |
Pfizer (Hospira) |
Retacrit |
Epogen |
December 16, 2014 |
Approved May 15, 2018 |
Filgrastim |
Sandoz |
Zarxio (filgrastim-sndz) |
Neupogen |
May 8, 2014 |
Approved March 6, 2015; marketed |
Filgrastim |
Apotex (Apobiologix) |
TBD |
Neupogen |
February 13, 2015 |
No FDA action reported (Complete response letter issued?) |
Infliximab |
Celltrion/Pfizer |
Inflectra (infliximab-dyyb) |
Remicade |
August 8, 2014 |
Approved April 5, 2016; marketed |
Infliximab |
Samsung Bioepis/Merck |
Renflexis (infliximab-abda) |
Remicade |
May 23, 2016 |
Approved April 21, 2017; marketed |
Infliximab |
Pfizer |
Ixifi (infliximab-qbtx) |
Remicade |
April 2017 |
Approved December 14, 2017, all indications; will not be marketed in US |
Etanercept |
Sandoz |
Erelzi (etanercept-szzs) |
Enbrel |
October 2, 2015 |
Approved August 31, 2016, all indications; not yet marketed |
Adalimumab |
Amgen |
Amjevita (adalimumab-atto) |
Humira |
November 25, 2015 |
Approved September 23, 2016, all indications; not yet marketed |
Pegfilgrastim |
Sandoz |
TBD |
Neulasta |
November 18, 2015 |
Complete response letter issued, June/July 2016; withdrew EMA application January 2017; new application possible 2019 |
Pegfilgrastim |
Apotex (Apobiologix) |
TBD |
Neulasta |
December 17, 2014 |
No FDA action reported (Complete response letter issued?) |
Pegfilgrastim |
Coherus Biosciences |
TBD |
Neulasta |
August 9, 2016/May 3, 2018 |
FDA Complete response letter issued June 12, 2017; New FDA decision expected by Nov 2, 2018 |
Insulin Glargine* |
Merck/Samsung Bioepis |
Lusduna™ |
Lantus |
August 5, 2016 |
FDA approved July 20, 2017 |
Trastuzumab |
Mylan/Biocon |
Ogivri™ (trastuzumab-dkst) |
Herceptin |
November 1, 2016 |
Approved December 3, 2017; not yet marketed |
Bevacizumab |
Amgen/Allergan |
Mvasi™ (bevacizumab-awwb) |
Avastin |
November 15, 2016 |
Approved September 14, 2017; not yet marketed |
Adalimumab |
Boehringer Ingelheim |
Cyltezo™ (adalimumab-adbm) |
Humira |
January 18, 2017 |
Approved August 29, 2017; not yet marketed |
Pegfilgrastim |
Mylan/Biocon |
Fulphila™ (pegfilgrastim-jmdb) |
Neulasta |
February 16, 2017 |
FDA approved June 4, 2018; marketed |
Rituximab |
Teva/Celltrion |
Truxima |
Rituxan |
June 30, 2017/May 29, 2018 |
FDA issued complete response letter April 5, 2018; Resubmitted 351(k) application May 29, 2018 |
Trastuzumab |
Pfizer |
TBD |
Herceptin |
Q3 2017 |
FDA issued complete response letter April 23, 2018; nonclinical issues cited |
Trastuzumab |
Teva/Celltrion |
Herzuma |
Herceptin |
July 31, 2017/June 18, 2018 |
FDA issued complete response letter April 5, 2018; Celltrion resubmitted BLA June 18, 2018 |
Trastuzumab |
Amgen/Allergan |
TBD |
Herceptin |
July 31, 2017 |
FDA issued complete response letter June 1, 2018 |
Filgrastim |
Pfizer |
Nevistym (filgrastim-aafi) |
Neupogen |
Q4 2017 |
FDA approved July 20, 2018 |
Trastuzumab |
Samsung Bioepis |
TBD |
Herceptin |
December 20, 2017 |
FDA decision expected Q4 2018 |
Filgrastim |
Adello |
TBD |
Neupogen |
September 12, 2017 |
FDA decision expected Q3 2018 |
Rituximab |
Sandoz |
Rixathon |
Rituxan |
September 12, 2017 |
FDA issued complete response letter May 2, 2018 |
Adalimumab |
Sandoz |
TBD |
Humira |
January 16, 2018 |
FDA decision expected Q4 2018 |
| *Product filed as follow-on biologic (351[a]), not as a biosimilar (351[k]).
Updated July 30, 2018. |
|||||