Biologic reference product | Biosimilar [B] / intended copy [IC] (proprietary name) |
Status (date [month/year]) |
Company | Indication |
Adalimumab (Humira®)a | ZRC3197 [IC] (Exemptia) | Approved in India (12/2014) | Zydus Cadila (India) | RA |
Adfrar [IC] | Approved in India (01/2016) | Torrent Pharmaceuticals (India) | AS, Ps, PsA, RA, UC | |
ONS-3010 [B/IC] | In phase III development | GMS Tenshi (China, India, Mexico) | — | |
LBAL [B/IC] | In phase III (RA) development | LG Life Sciences (Korea)/Mochida Pharmaceutical (Japan) | — | |
BCD 057 [B/IC] | In phase III (Ps, RA) development | Biocad (Russia) | — | |
PBP1502 [B/IC] | In phase I development | Prestige BioPharma (Singapore) | — | |
N/A [B/IC] | In development | PlantForm (Canada)/ Axis Biotec Brasil (Brazil) |
— | |
N/A [B/IC] | In preclinical development | mAbxience (Spain) | — | |
CT-P17 | In pipeline | Celltrion (Korea) | — | |
Etanercept (Enbrel®)b |
SB4 [B] (Brenzys®) |
Approved in South Korea (09/2015), Australia (07/2016), Canada (08/2016) | Samsung Bioepis (Korea)/MSD (US) | axSpA, JIA, ped Ps, Ps, PsA, RA |
GP2015 [B] (Erelzi®) |
Approved in Canada (08/2017) | Sandoz (Switzerland) | axSpA, JIA, ped Ps, Ps, PsA, RA | |
HD203 [B] (Davictrel) |
Approved in Korea (11/2014) | Hanwha Chemical (Korea) | AS, RA, Ps, PsA | |
LBEC0101 [B] | Phase III trials ongoing in RA; filed for approval in Japan |
LG Life Sciences (Korea)/Mochida Pharmaceutical (Japan) | — | |
ENIA11 [B] (TuNEX®) |
Registered (RA; Taiwan); Phase III trials in RA/AS (Japan, Korea) | Mycenax Biotech/ TSH Biopharm (Taiwan) |
— | |
CT-P05 [B/IC] | In development | Celltrion (Korea) | — | |
AVGO1 [B/IC] (Avent™) | Patented in India (2010); similarity demonstrated in preclinical trialse | Avesthagen (India) | — | |
Intacept® [B/IC] | Approved in India (03/2015) | Intas Pharmaceuticals (India) | AS, JIA, RA, Ps, PsA | |
N/A [B/IC] | In preclinical development | mAbxience (Spain) | — | |
PRX-106 [B/IC] | In preclinical development | Protalix Biotherapeutics (Israel) | — | |
Etanar®/Etart®/Etacept®/ Yisaipu® [IC] |
Approved in Colombia, Mexico, India, China | Shanghai CP Guojian (China) Cipla (India) |
AS, RA, Ps AS, JIA, RA, Ps, PsA |
|
Infinitam® | Approved in Mexico | Probiomed (Mexico) | RA | |
Infliximab (Remicade)c |
CT-P13 [B/IC] (Remsima/Inflectra/others) | Approved in 79 countries (as of 01/2017) |
Celltrion | AS, CD, Ps, PsA, RA, UC |
SB2 [B] (Renflexis) | Approved in Korea (12/2015), Australia (11/2016) | Samsung Bioepis/MSD (Korea/US) | AS, CD, Ps, PsA, RA, UC |
|
Infliximab BS [B/IC] | Approved in Japan (07/2014) | Nippon Kayaku (Japan) | CD, RA, UC | |
BOW015 [IC] (Infimab) | Approved in India (09/2014); global phase III study initiated in RA (02/2016) | Ranbaxy Laboratories/Epirus Biopharmaceuticals (India/US) | AS, CD, Ps, PsA, RA, CD |
|
NI-071 [B/IC] (Nichi-Iko) | Approved in Japan (09/2017) | Nichi-Iko/Zeria (Japan) | — | |
STI-002 [B/IC] | Positive phase III study findings in RA reported (05/2016) | MabTech/Sorrento Therapeutics (China/US) | — | |
Rituximab (MabThera/Rituxan)d |
CT-P10 (Truxima) | Approved in Korea (11/2016) | Celltrion | RA |
BCD-020 (Acellbia [Russia/India]; USMAL [Bolivia/Honduras]) | Approved in Russia, Bolivia, Honduras Pre-registration for RA in India (2017) |
Biocad (Russia) | ||
Reditux | Approved in Bolivia, Chile, Ecuador, Paraguay, Peru, India (2007) | Dr. Reddy’s Laboratories | RA | |
Novex | Approved in Argentina (2013) | mAbxience/Laboratorio Elea (Spain/Argentina) | RA | |
Kikuzubam | Approved in Bolivia, Chile, Mexico, Peru | Probiomed (Mexico) | RA | |
MabTas | Approved in India (2013) | Intas Biopharmaceuticals (India) | RA | |
N/A | Approved in India (2013) | Zenotech Laboratories (India) | RA | |
Maball | Approved in India (2015) | Hetero Group (India) | RA | |
N/A [IC] | In development | Torrent Pharmaceuticals (India) | — | |
HLX01 [IC] | In phase III development | Shanghai Henlius Biotech (China) | — | |
JHL1101 | In phase III development | JHL Biotech (China) |