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‘Similar biologics’ approved and marketed in India Posted 07/09/2012
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].
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 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, 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, 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.
Editor’s comment 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 Standards for biosimilars or ‘alternative’ biologicals in India
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Chronic B-cell lymphocytic leukaemia
Chronic hepatitis C
Chronic hepatitis C
Source: CDSCO (Central Drugs Standard Control Organization)
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.
Biosimilars approved in Europe
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
Source: CDSCO, Claris Lifesciences, Dr Reddy’s, EMA, Medline India, Reliance Life Sciences, Wockhardt
Comments (1)
New molecules Launched by Dr. Reddy's Lab, India posted 05/10/2019 - by Dr. Vikas Chandrawanshi
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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