Product name*
|
Active substance
|
Therapeutic area**
|
Approval/ launch date in India#
|
Company
|
AbcixiRel
|
abciximab
|
Angina, Cardiac ischemia
|
23 Apr 2013
|
Reliance Life Sciences
|
Acellbia
|
rituximab
|
Non-Hodgkin lymphoma Chronic B-cell lymphocytic leukaemia
|
20 Jun 2017
|
Biocad
|
Actorise
|
darbepoetin alfa
|
Anaemia, Cancer, Chronic kidney failure
|
6 Jan 2014 [7]
|
Cipla/Hetero
|
Adfrar
|
adalimumab
|
Ankylosing spondylitis, Plaque psoriasis, Psoriatic arthritis, Rheumatoid arthritis, Ulcerative colitis
|
11 Jan 2016
|
Torrent Pharmaceuticals
|
Basalog
|
insulin glargine
|
Diabetes
|
2009
|
Biocon
|
Bevacirel
|
bevacizumab
|
Colorectal cancer
|
10 Jun 2016 [8]
|
Reliance Life Sciences (Lupin)
|
Biovac-B
|
hepatitis B vaccine
|
Hepatitis B
|
2000
|
Wockhardt
|
CanMab
|
trastuzumab
|
Breast cancer
|
23 Oct 2013
|
Biocon
|
Ceriton
|
epoetin alfa
|
Anaemia, Cancer, Chronic kidney failure
|
NR
|
Ranbaxy
|
Choriorel
|
chorionic gonadotrophin hormone r-hCG
|
Female infertility
|
22 Jun 2011
|
Reliance Life Sciences
|
Cizumab
|
bevacizumab
|
Colorectal cancer
|
27 Jun 2016 [9]
|
Hetero
|
Cresp
|
darbepoetin alfa
|
Anaemia, Cancer, Chronic kidney failure
|
23 Mar 2010
|
Dr. Reddy’s Laboratories
|
Darbatitor
|
darbepoetin alfa
|
Anaemia, Cancer, Chronic kidney failure
|
2014 [10]
|
Torrent Pharmaceuticals
|
Emgrast
|
filgrastim
|
Cancer, Neutropenia
|
16 Mar 2010
|
Gennova Biopharmaceuticals (Emcure)
|
Epofer
|
epoetin alfa
|
Anaemia, Cancer, Chronic kidney failure
|
NR
|
Emcure
|
Epofit/Erykine
|
epoetin alfa
|
Anaemia, Cancer, Chronic kidney failure
|
Aug 2005
|
Intas Pharmaceuticals
|
Eporec
|
erythropoietin
|
Anaemia, Chronic kidney failure
|
9 Aug 2011
|
Bioviz Technologies
|
Epotin
|
epoetin alfa
|
Anaemia, Cancer, Chronic kidney failure
|
NR
|
Claris Lifesciences
|
Erypro
|
epoetin alfa
|
Anaemia, Cancer, Chronic kidney failure
|
NR
|
Biocon
|
Etacept
|
etanercept
|
Ankylosing spondylitis, Rheumatoid arthritis, Psoriatic arthritis, Psoriasis, Juvenile rheumatoid arthritis
|
Apr 2013 [9]
|
Cipla
|
Exemptia
|
adalimumab
|
Rheumatoid arthritis
|
25 Sep 2014
|
Zydus Cadila
|
Fegrast
|
filgrastim
|
Cancer, Hematopoietic stem cell transplantation, Neutropenia
|
NR
|
Claris Lifesciences
|
Filgrastim
|
filgrastim
|
Neutropenia
|
22 Oct 2013
|
Cadila Pharmaceutical
|
Filgrastim
|
filgrastim
|
Neutropenia
|
5 Mar 2013
|
Lupin
|
Filgrastim
|
filgrastim
|
Neutropenia
|
3 Jun 2013
|
USV
|
Folisurge
|
follitropin alfa (follicle stimulating hormone)
|
Female infertility, Spermatogenesis in men
|
14 May 2013
|
Intas Pharmaceuticals
|
FostiRel
|
follitropin beta (follicle stimulating hormone)
|
Female infertility
|
30 Apr 2010
|
Reliance Life Sciences
|
Glaritus
|
insulin glargine
|
Diabetes mellitus
|
Mar 2009
|
Wockhardt
|
Grafeel
|
filgrastim
|
Neutropenia, Hematopoietic stem cell transplantation, Cancer
|
NR
|
Dr. Reddy’s Laboratories
|
Infimab
|
infliximab
|
Ankylosing spondylitis, Crohn’s disease, Psoriasis, Psoriatic arthritis, Rheumatoid arthritis, Ulcerative colitis
|
15 Sep 2014 [11]
|
Epirus Biopharmaceuticals
|
Insugen
|
human insulin
|
Diabetes mellitus
|
NR
|
Biocon
|
Insulin
|
insulin
|
Diabetes mellitus
|
9 Aug 2011
|
Gland Pharma
|
Intacept
|
etanercept
|
Ankylosing spondylitis, Juvenile idiopathic arthritis Psoriasis, Psoriatic arthritis, Rheumatoid arthritis
|
Mar 2015 [12]
|
Intas Pharmaceuticals
|
Intalfa
|
interferon alfa-2b
|
Carcinoid tumour, Chronic hepatitis B, Chronic hepatitis C, Hairy cell leukaemia, Chronic myelogenous leukaemia, BCR-ABL positive, Follicular lymphoma, Malignant melanoma, Multiple myeloma
|
Apr 2007
|
Intas Pharmaceuticals
|
Krabeva
|
bevacizumab
|
metastatic colorectal cancer, lung cancer, kidney cancer, cervical cancer, ovarian cancer, brain cancers
|
23 Nov 2017 [13]
|
Biocon
|
Maball
|
rituximab
|
Lymphoma, Non-Hodgkin’s Lymphoma
|
3 Feb 2015 [14]
|
Hetero Group
|
MabTas
|
rituximab
|
Lymphoma, Non-Hodgkin’s Lymphoma
|
26 Feb 2013
|
Intas Pharmaceuticals
|
Molgramostim
|
Recombinant human granulocyte macrophage colony stimulating factor (molgramostim)
|
Neutropenia
|
14 May 2013
|
Zenotech Laboratories
|
Mirel
|
reteplase (tissue plasminogen activator)
|
Myocardial infarction
|
2009
|
Reliance Life Sciences
|
Myokinase
|
streptokinase
|
Acute myocardial infarction, Deep venous thrombosis, Acute pulmonary embolism
|
NR
|
Biocon
|
Neukine
|
filgrastim
|
Neutropenia, Hematopoietic stem cell transplantation, Cancer
|
Jul 2004
|
Intas Pharmaceuticals
|
Neupeg
|
pegfilgrastim
|
Cancer, Neutropenia
|
Aug 2007
|
Intas Pharmaceuticals
|
Nufil
|
filgrastim
|
Cancer, Neutropenia
|
NR
|
Biocon
|
Pegex
|
pegfilgrastim
|
Cancer, Neutropenia
|
29 Jan 2010
|
Gennova Biopharmaceuticals (Emcure)
|
Peg-filgrastim
|
pegfilgrastim
|
Cancer, Neutropenia
|
3 Sep 2013
|
Lupin
|
Peg-grafeel
|
pegfilgrastim
|
Cancer, Neutropenia
|
10 May 2011
|
Dr Reddy’s Laboratories
|
Peg-interferon alfa 2b
|
Pegylated recombinant human interferon alfa 2b
|
Chronic hepatitis B, Chronic hepatitis C
|
25 Apr 2013
|
Intas Pharmaceuticals
|
Platelet derived growth factor
|
rh-PDGF-BB + β-TCP
|
Peridontal defect, Gingival recession
|
28 Apr 2010
|
Virchow Biotech
|
Rasburicase
|
rasburicase
|
Malignancy associated hyperuricemia
|
28 Aug 2012
|
Virchow Biotech
|
Razumab
|
ranibizumab
|
Wet macular degeneration, Macular edema, Degenerative myopia, Diabetes complications
|
19 Jun 2015 [15]
|
Intas Pharmaceuticals
|
Reditux
|
rituximab
|
Leukaemia, Lymphoma, Rheumatoid arthritis
|
30 Apr 2007
|
Dr. Reddy’s Laboratories
|
Relibeta
|
interferon beta-1a
|
Multiple sclerosis
|
2 May 2011
|
Reliance Life Sciences
|
Reliferon
|
interferon alfa-2b
|
BCR-ABL positive, Carcinoid tumour, Chronic hepatitis B, Chronic hepatitis C, Chronic myelogenous leukaemia, Follicular lymphoma, Hairy cell leukaemia, Melanoma Multiple myeloma
|
2008
|
Reliance Life Sciences
|
Religrast
|
filgrastim
|
Neutropenia
|
2008
|
Reliance Life Sciences
|
Relipoietin
|
epoetin alpha
|
Anaemia, Autologous blood transfusion, Chronic kidney failure, HIV
|
2008
|
Reliance Life Sciences
|
Repoitin
|
erythropoietin
|
Anaemia, Chronic kidney failure
|
29 Nov 2011
|
Serum Institute of India
|
RituxiRel
|
rituximab
|
Non-Hodgkin’s Lymphoma, Rheumatoid arthritis
|
12 Feb 2015
|
Reliance Life Sciences
|
Rituximab
|
rituximab
|
Non-Hodgkin’s Lymphoma
|
27 Feb 2013
|
Zenotech Laboratories
|
Shankinase
|
streptokinase
|
Arterial occlusions, Deep vein thrombosis, Pulmonary embolism
|
Jun 2004
|
Shantha Biotechnics/Merieux Alliance
|
Shanferon
|
interferon alfa-2b
|
BCR-ABL positive, Carcinoid Tumour, Chronic hepatitis B, Chronic hepatitis C, Chro,nic myelogenous leukaemia, Follicular lymphoma, Hairy cell leukaemia, Melanoma, Multiple myeloma
|
Apr 2002
|
Shantha Biotechnics/Merieux Alliance
|
Shanpoietin
|
erythropoetin
|
Anaemia, Chronic kidney failure
|
Jan 2005
|
Shantha Biotechnics/Merieux Alliance
|
Terifrac
|
teriparatide (parathyroid hormone)
|
Post menopausal women with osteoporosis who are at high risk for fracture
|
1 Nov 2010
|
Intas Pharmaceuticals
|
Teriparatide
|
teriparatide (parathyroid hormone)
|
Post menopausal women with osteoporosis who are at high risk for fracture
|
21 Aug 2012
|
Cadila Healthcare
|
Teriparatide
|
teriparatide (parathyroid Hormone)
|
Post menopausal women with osteoporosis who are at high risk for fracture
|
13 Aug 2012
|
USV
|
Wepox
|
epoetin alfa
|
Anaemia, Cancer, Chronic kidney failure
|
Mar 2001
|
Wockhardt
|
Wosulin
|
human insulin
|
Diabetes mellitus
|
13 Aug 2003
|
Wockhardt
|
Zavinex
|
interferon alfa-2b
|
Chronic hepatitis B, Chronic hepatitis C
|
21 Jun 2011
|
Cadila Healthcare
|
Zyrop
|
erythropoietin
|
Chronic kidney failure
|
28 Apr 2010
|
Cadila Healthcare
|
* Where brand-name is not known active substance name is given;
** Therapeutic area taken from company information, from originator product information on EMA website or from CDSCO information; NR: not reported; # ‘similar biologics’ launched in India before the Indian ‘similar biologics’ guideline came into effect on 15 September 2012, were approved using an ad-hoc abbreviated procedure on a case-by-case basis. Source: CDSCO (Central Drugs Standard Control Organization)
|
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