Table 3: Biosimilars and intended copies approved, or in development, outside of the European Union/United States (US) for chronic inflammatory diseases.

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)

aReference [49]. bReference [50]. cReference [51]. dReference [52]. eReference [53]. AS: Ankylosing Spondylitis; axSpA: axial spondyloarthritis (non-radiographic axSpA and AS); CD: Crohn’s disease; JIA: Juvenile Idiopathic Arthritis; ped Ps: pediatric psoriasis (plaque); Ps: psoriasis (plaque); PsA: psoriatic arthritis; RA: Rheumatoid Arthritis; UC: Ulcerative Colitis.