‘Similar biologics’ approved and marketed in India

Biosimilars/General | Posted 07/09/2012 post-comment1 Post your comment

Last update: 15 February 2018

There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory authorities call these products, existed in India until 2012. This has been the case despite the fact that the requirements for granting regulatory approval for such ‘similar biologics’ required more data than for a simple generic drug application [1].

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India announced the release of draft regulatory guidelines for ‘similar biologics’ at the BIO industry conference in Boston, USA, on 19 June 2012. Finalized guidelines were implemented on 15 September 2012. The guidelines outline a simple abridged procedure for evaluation of ‘similar biologics’ which have been approved and marketed in India, Europe or USA for more than four years [2]. These guidelines were then revised and updated, with new guidelines, which came into effect in August 2016 [3].

The regulatory bodies responsible for approval of ‘similar biologics’ in India are the Department of Biotechnology (DBT – under the Ministry of Science and Technology), through its Review Committee on Genetic Manipulation (RCGM), and the Central Drugs Standard Control Organization (CDSCO – under the Ministry of Health and Family Welfare).

India has, by far, demonstrated the greatest acceptance of ‘similar biologics’. According to our research at GaBI Online, the first ‘similar biologic’ was approved and marketed in India for a hepatitis B vaccine in 2000. In recent years over 50 biopharmaceutical products have been approved for marketing in India, with more than half of them being ‘similar biologics’ [4-6], see Table 1.

Table 1: ‘Similar biologics’ approved and marketed in India 

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)

Editor’s comment
India’s list of approved and marketed ‘similar biologics’ is constantly changing. If you have information to update Table 1, please send us your data here.

It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Related articles
Biosimilars approved in Europe

Standards for biosimilars or ‘alternative’ biologicals in India

References
1.  Joshi SR, Biosimilar peptides: need for pharmacovigilance. J Assoc Physicians India. 2011;59 Suppl:44-7.
2.  GaBI Online - Generics and Biosimilars Initiative. India releases draft ‘similar biologic’ guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Guidelines/India-releases-draft-similar-biologic-guidelines 
3.  GaBI Online - Generics and Biosimilars Initiative. India updates its similar biologics guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 15]. Available from: www.gabionline.net/Guidelines/India-updates-its-similar-biologics-guidelines
4.  Jayaraman K. India’s Cipla sets sights on Avastin, Herceptin and Enbrel. Nature Biotechnol. 2010 Sep;28(9):883-4.
5. Mody R, et al. How Similar are biosimilars in India? Pharmafocus Asia. [monograph on Internet]. c2004-2012 Ochre media; [cited 2018 Feb 15]; Available from: www.pharmafocusasia.com/research_development/blind-comparative-study.html
6. Som N. India on biologics trail. Biospectrum. 13 Feb 2012.
7. GaBI Online - Generics and Biosimilars Initiative. Darbopoetin alfa ‘similar biologic’ launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 19]. Available from: www.gabionline.net/Biosimilars/News/Darbopoetin-alfa-similar-biologic-launched-in-India
8. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab similar biologics launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 19]. Available from: www.gabionline.net/Biosimilars/News/Bevacizumab-similar-biologics-launched-in-India
9. GaBI Online - Generics and Biosimilars Initiative. Cipla launches first etanercept ‘similar biologic’ in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/News/Cipla-launches-first-etanercept-similar-biologic-in-India
10.  GaBI Online - Generics and Biosimilars Initiative. Torrent licenses three ‘similar biologics’ from Reliance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 30]. Available from: www.gabionline.net/Biosimilars/News/Torrent-licenses-three-similar-biologics-from-Reliance 
11.  GaBI Online - Generics and Biosimilars Initiative. Infliximab ‘similar biologic’ receives Indian approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-similar-biologic-receives-Indian-approval
12.   GaBI Online - Generics and Biosimilars Initiative. Indian biosimilars manufacturers make progress [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 19]. Available from: www.gabionline.net/Biosimilars/News/Indian-drugmakers-make-progress-with-candidate-biosimilarsgabionline.net/Biosimilars/News/Bevacizumab-similar-biologic-launched-in-India
14. GaBI Online - Generics and Biosimilars Initiative. Rituximab similar biologic launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 28]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-similar-biologic-launched-in-India
15.  GaBI Online - Generics and Biosimilars Initiative. Ranibizumab similar biologic launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 26]. Available from: www.gabionline.net/Biosimilars/News/Ranibizumab-similar-biologic-launched-inIndia

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Source: CDSCO, Claris Lifesciences, Dr Reddy’s, EMA, Medline India, Reliance Life Sciences, Wockhardt

comment icon Comments (1)
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Posted 05/10/2019 by Dr. Vikas Chandrawanshi
New molecules Launched by Dr. Reddy's Lab, India

Dr. Reddy's Lab have launched 2 more biosimilars. Please add those also in the list.

1) Hervycta (Trastuzumab Biosimilar) in 2018

https://www.centerforbiosimilars.com/news/trastuzumab-biosimilar-hervycta-launches-in-india

2) Versavo (Bevacizumab Biosimilar) in 2019

https://www.bigmoleculewatch.com/2019/08/19/dr-reddys-launches-versavo-bevacizumab-in-india/

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