| Biologic reference product | Biosimilar product (proprietary name) | Regulatory authority | |||||
| EMA | FDA | ||||||
| Status (date [month/year]) |
Company | Indication | Status (date [month/year]) |
Company | Indication | ||
| Adalimumab (Humira®)a |
ABP 501 (Amgevita® [EU/US]; Solymbic [EU]) | Approved (01/2017) | Amgen | CD, HS, JIA, Ps, PsA, RA, UC, uveitis | Approved (09/2016) | Amgen | AS, CD, JIA, Ps, PsA, RA, UC |
| BI 695501 (Cyltezo® [US]) | Approved (11/2017) | Boehringer Ingelheim | — | Approved (08/2017) | Boehringer Ingelheim | AS, CD, JIA, Ps, PsA, RA, UC | |
| SB5 (Imraldi®) | Approved (06/2016) | Samsung Bioepis | CD, HS, JIA, Ps, PsA, RA, UC, uveitis | — | — | — | |
| FKB327 | MAA submitted (05/2017) | Fujifilm Kyowa Kirin Biologics |
— | — | — | — | |
| GP2017 | MAA submitted (06/2017) | Sandoz | — | — | — | — | |
| ONS-3010 | In phase III development |
Oncobiologics | — | In phase III development |
Oncobiologics | — | |
| PF-06410293 | — | — | — | In phase III (RA) development |
Pfizer | — | |
| M923 | — | — | — | In phase III (Ps) development (positive results reported in 2016) |
Momenta Pharma-ceuticals | — | |
| CHS-1420 | — | — | — | In phase III (Ps) development (positive results reported in 2017) |
Coherus Biosciences | — | |
| N/A | In preclinical development |
Adello Biologics |
— | In preclinical development |
Adello Biologics |
— | |
| N/A | In pipeline |
AET BioTech/ BioXpress Therapeutics | — | — | — | — | |
| Etanercept (Enbrel®)b |
SB4 (Benepali®) | Approved (01/2016) | Samsung Bioepis | axSpA, JIA, Ps, ped Ps, PsA, RA | — | — | — |
| GP2015 (Erelzi®) | Approved (07/2017) | Sandoz | axSpA, JIA, Ps, ped Ps, PsA, RA | Approved (08/2016) | Sandoz | axSpA, JIA, Ps, ped Ps, PsA, RA | |
| CHS-0214/BAX 2200 [B] | — | — | — | Global phase III trials: Ps (RaPsODY) and RA |
Coherus/ Baxalta (US) |
— | |
| BX2922 [B/IC] | In development | BioXpress Therapeutics (Switzerland) | — | — | — | — | |
| Infliximab (Remicade®)c |
CT-P13 (Remsima® [EU]; Inflectra® [US]) |
Approved (09/2013) | Celltrion | AS, CD, Ps, PsA, RA, UC | Approved (04/2016) | Hospira | AS, CD, Ps, PsA, RA, UC |
| SB2 (Flixabi® [EU]; Renflexis® [US]) | Approved (05/2016) | Samsung Bioepis | AS, CD, Ps, PsA, RA, UC | Approved (04/2017) | Merck | AS, CD, Ps, PsA, RA, UC |
|
| PF-06438179 (IXIFI™) | Approved (12/2017) | Pfizer | AS, CD, Ps, PsA, RA, UC |
Approval recommended (03/2018) | Sandoz | AS, CD, Ps, PsA, RA, UC |
|
| STI-002 | — | — | — | Phase III study in RA (05/2016) | Sorrento Therapeutics (US) | — | |
| NI-071 | — | — | — | Phase III study in RA (RADIANCE; completion: 12/2018) | Sagent (US) | — | |
| N/A | In development | BioXpress Therapeutics (Switzerland) | — | — | — | — | |
| ABP 710 | — | — | — | In development (positive results of functional similarity tests reported in 2017) |
Amgen (US) | — | |
| Rituximab (MabThera®/ Rituxan®)d |
CT-P10 (Blitzima/ Ritemvia/Truxima [EU]) | Approved (07/2017) | Celltrion | RA | BLA submitted (06/2017) | Teva/Celltrion | RA |
| APB 798 | — | — | — | In phase III (RA) development | Amgen/ Allergan |
— | |
| APO-RITUX | — | — | — | In phase III (RA) development | Apotex (Apobiologix; Canada) | — | |
| PF-05280586 | — | — | — | In phase III development | Pfizer (US) | — | |
| GP2013 (Rixathon/ Riximyo) | Approved (06/2017) | Sandoz (Switzerland) | RA | BLA rejected (05/2018) | — | — | |
| N/A [B] | In development | BioXpress Therapeutics (Switzerland) | — | — | — | — | |
| JHL1101 | In development | JHL Biotech (China) | — | — | — | ||
| N/A [B] | In development | Mabion (Poland)/ Mylan (Ireland) | — | — | — | — | |
| N/A | In development | Richter (Hungary)/ Stada (Germany) |
— | — | — | — | |