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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 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. |
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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
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/
Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
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