BIOSIMILAR DRUG STATUS IN THE US: FDA FILING DATES AND ACTIONS |
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Biosimilar |
Manufacturer |
Brand Name & Designation |
Innovator Product |
FDA Filing Date |
Status |
Epoetin |
Pfizer (Hospira) |
Retacrit |
Epogen |
December 16, 2014 |
FDA Advisory Committee voted May 25, 2017 14-1 to recommend for approval; FDA issued 2nd complete response letter June 22, 2017 |
Filgrastim |
Sandoz |
Zarxio (filgrastim-sndz) |
Neupogen |
May 8, 2014 |
Approved March 6, 2015 |
Filgrastim |
Apotex |
TBD |
Neupogen |
February 13, 2015 |
No FDA Action |
Infliximab |
Celltrion/Pfizer |
Inflectra (infliximab-dyyb) |
Remicade |
August 8, 2014 |
Approved April 5, 2016 |
Infliximab |
Samsung Bioepis/Merck |
Renflexis (infliximab-abda) |
Remicade |
May 23, 2016 |
Approved April 21, 2017 |
Etanercept |
Sandoz |
Erelzi (etanercept-szzs) |
Enbrel |
October 2, 2015 |
Approved August 31, 2016, all indications |
Adalimumab |
Amgen |
Amjevita (adalimumab-atto) |
Humira |
November 25, 2015 |
Approved September 23, 2016, all indications |
Pegfilgrastim |
Sandoz |
TBD |
Neulasta |
November 18, 2015 |
Complete response letter issued, June/July 2016; withdrew EMA application January 2017 |
Pegfilgrastim |
Apotex |
TBD |
Neulasta |
December 17, 2014 |
No FDA action (Complete response letter issued?) |
Pegfilgrastim |
Coherus Biosciences |
TBD |
Neulasta |
August 9, 2016 |
FDA Complete response letter issued June 12, 2017 |
Insulin Glargine* |
Merck/Samsung Bioepis |
TBD |
Lantus |
August 5, 2016 |
FDA decision expected Q3, 2017 |
Trastuzumab |
Mylan/Biocon |
TBD |
Herceptin |
November 1, 2016 |
FDA Advisory Committee voted 16-0 to recommend approval; FDA decision originally expected by 9/3, delayed until 12/3/17 |
Bevacizumab |
Amgen/Allergan |
TBD |
Avastin |
November 15, 2016 |
Approved September 14, 2017 |
Adalimumab |
Boehringer Ingelheim |
Cyltezo™ (adalimumab-adbm) |
Humira |
January 18, 2017 |
Approved August 29, 2017 |
Pegfilgrastim |
Mylan/Biocon |
TBD |
Neulasta |
February 16, 2017 |
FDA issued complete response letter Oct. 10, 2017 |
Rituximab |
Celltrion |
Truxima |
Rituxan |
June 30, 2017 |
FDA decision expected Q1-2 2018 |
Trastuzumab |
Celltrion |
Herzuma |
Herceptin |
July 31, 2017 |
FDA decision expected Q2 2018 |
Trastuzumab |
Amgen/Allergan |
TBD |
Herceptin |
July 31, 2017 |
FDA decision expected Q2 2018 |
Filgrastim |
Adello Biologic |
TBD |
Neupogen |
September 12, 2017 |
FDA decision expected Q3 2018 |
Rituximab |
Sandoz |
TBD |
Rituxan |
September 12, 2017 |
FDA decision expected Q3 2018 |
| *Product filed as follow-on biologic (351[a]), not as a biosimilar (351[k]).
Updated October 11, 2017 |
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