‘Similar biologics’ approved and marketed in India Posted 07/09/2012

Last update: 22 September 2017

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, have existed in India until recently. 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].

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’ [3], see Table 1.

Table 1: ‘Similar biologics’ approved and marketed in India [3, 4, 7, 8]

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 [4]

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 [5]

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 [5]

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 [9]

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 [6]

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 [10]

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 [11]

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

Maball

rituximab

Lymphoma, Non-Hodgkin’s Lymphoma

3 Feb 2015 [12]

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 [13]

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.  Jayaraman K. India’s Cipla sets sights on Avastin, Herceptin and Enbrel. Nature Biotechnol. 2010 Sep;28(9):883-4.
4. 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
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6. 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
7.  Mody R, et al. How Similar are biosimilars in India? Pharmafocus Asia. [monograph on Internet]. c2004-2012 Ochre media; [cited 2014 Sep 26]; Available from: www.pharmafocusasia.com/research_development/blind-comparative-study.html
8.  Som N. India on biologics trail. Biospectrum. 13 Feb 2012.
9.  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 
10.  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
11.   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-biosimilars
12. 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
13.  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

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