A biologic medicine is derived from living organisms and is manufactured through highly involved and stringently controlled biotechnology processes. As biologic medicines, biosimilars are inherently different from generics due to their molecular size and structure, and the complexity and cost of their development. Biosimilars also have significantly higher research and development costs and risks and are more complex to manufacture than small-molecule generics.
Biosimilars have the potential to provide additional treatment options at lower cost, but development requires significant investment. Biosimilar development may take five to nine years and cost more than $100 million, not including regulatory fees. A generic, however, costs $1-2 million and takes approximately two years to develop.
Following biosimilar medicines approved in India, they are listed below:-
| Product Name | Active Substance | Therapeutic Area | Company |
| AbcixiRel | abciximab | Angina, Cardiac ischemia | Reliance Life Sciences |
|
Acellbia
|
rituximab
|
Non-Hodgkin lymphoma |
Biocad
|
| Chronic B-cell lymphocytic leukaemia | |||
| Actorise | darbepoetin alfa | Anaemia, Cancer, Chronic kidney failure | Cipla/Hetero |
| Adfrar | adalimumab | Ankylosing spondylitis, Plaque psoriasis, Psoriatic arthritis, Rheumatoid arthritis, Ulcerative colitis | Torrent Pharmaceuticals |
| Basalog | insulin glargine | Diabetes | Biocon |
| Bevacirel | bevacizumab | Colorectal cancer | Reliance Life Sciences (Lupin) |
| Biovac-B | hepatitis B vaccine | Hepatitis B | Wockhardt |
| CanMab | trastuzumab | Breast cancer | Biocon |
| Ceriton | epoetin alfa | Anaemia, Cancer, Chronic kidney failure | Ranbaxy |
| Choriorel | chorionic gonadotrophin hormone r-hCG | Female infertility | Reliance Life Sciences |
| Cizumab | bevacizumab | Colorectal cancer | Hetero |
| Cresp | darbepoetin alfa | Anaemia, Cancer, Chronic kidney failure | Dr. Reddy’s Laboratories |
| Darbatitor | darbepoetin alfa | Anaemia, Cancer, Chronic kidney failure | Torrent Pharmaceuticals |
| Emgrast | filgrastim | Cancer, Neutropenia | Gennova Biopharmaceuticals (Emcure) |
| Epofer | epoetin alfa | Anaemia, Cancer, Chronic kidney failure | Emcure |
| Epofit/Erykine | epoetin alfa | Anaemia, Cancer, Chronic kidney failure | Intas Pharmaceuticals |
| Eporec | erythropoietin | Anaemia, Chronic kidney failure | Bioviz Technologies |
| Epotin | epoetin alfa | Anaemia, Cancer, Chronic kidney failure | Claris Lifesciences |
| Erbitux | Cetuximab | Colorectal carcinoma | Merck Ltd |
| Erypro | epoetin alfa | Anaemia, Cancer, Chronic kidney failure | Biocon |
| Etacept | etanercept | Ankylosing spondylitis, Rheumatoid arthritis, Psoriatic arthritis, Psoriasis, Juvenile rheumatoid arthritis | Cipla |
| Exemptia | adalimumab | Rheumatoid arthritis | Zydus Cadila |
| Fegrast | filgrastim | Cancer, Hematopoietic stem cell transplantation, Neutropenia | Claris Lifesciences |
| Filgrastim | filgrastim | Neutropenia | Cadila Pharmaceutical |
| Filgrastim | filgrastim | Neutropenia | Lupin |
| Filgrastim | filgrastim | Neutropenia | USV |
| Folisurge | follitropin alfa (follicle stimulating hormone) | Female infertility, Spermatogenesis in men | Intas Pharmaceuticals |
| FostiRel | follitropin beta (follicle stimulating hormone) | Female infertility | Reliance Life Sciences |
| Glaritus | insulin glargine | Diabetes mellitus | Wockhardt |
| Grafeel | filgrastim | Neutropenia, Hematopoietic stem cell transplantation, Cancer | Dr. Reddy’s Laboratories |
| Herceptin | Trastuzumab | Breast cancer | Roche Products India Pvt Ltd |
| Infimab | infliximab | Ankylosing spondylitis, Crohn’s disease, Psoriasis, Psoriatic arthritis, Rheumatoid arthritis, Ulcerative colitis | Epirus Biopharmaceuticals |
| Insugen | human insulin | Diabetes mellitus | Biocon |
| Insulin | insulin | Diabetes mellitus | Gland Pharma |
| Intacept | etanercept | Ankylosing spondylitis, Juvenile idiopathic arthritis Psoriasis, Psoriatic arthritis, Rheumatoid arthritis | 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 | Intas Pharmaceuticals |
| Krabeva | bevacizumab | metastatic colorectal cancer, lung cancer, kidney cancer, cervical cancer, ovarian cancer, brain cancers | Biocon |
| Maball | rituximab | Lymphoma, Non-Hodgkin’s Lymphoma | Hetero Group |
| MabTas | rituximab | Lymphoma, Non-Hodgkin’s Lymphoma | Intas Pharmaceuticals |
| Molgramostim | Recombinant human granulocyte macrophage colony stimulating factor (molgramostim) | Neutropenia | Zenotech Laboratories |
| Mirel | reteplase (tissue plasminogen activator) | Myocardial infarction | Reliance Life Sciences |
| Myokinase | streptokinase | Acute myocardial infarction, Deep venous thrombosis, Acute pulmonary embolism | Biocon |
| Neukine | filgrastim | Neutropenia, Hematopoietic stem cell transplantation, Cancer | Intas Pharmaceuticals |
| Neupeg | pegfilgrastim | Cancer, Neutropenia | Intas Pharmaceuticals |
| Nufil | filgrastim | Cancer, Neutropenia | Biocon |
| Pegex | pegfilgrastim | Cancer, Neutropenia | Gennova Biopharmaceuticals (Emcure) |
| Peg-filgrastim | pegfilgrastim | Cancer, Neutropenia | Lupin |
| Peg-grafeel | pegfilgrastim | Cancer, Neutropenia | Dr Reddy’s Laboratories |
|
Peg-interferon alfa 2b
|
Pegylated recombinant human interferon alfa 2b
|
Chronic hepatitis B, |
Intas Pharmaceuticals
|
| Chronic hepatitis C | |||
| Platelet derived growth factor | rh-PDGF-BB + β-TCP | Peridontal defect, Gingival recession | Virchow Biotech |
| Rasburicase | rasburicase | Malignancy associated hyperuricemia | Virchow Biotech |
| Razumab | ranibizumab | Wet macular degeneration, Macular edema, Degenerative myopia, Diabetes complications | Intas Pharmaceuticals |
| Reditux | rituximab | Leukaemia, Lymphoma, Rheumatoid arthritis | Dr. Reddy’s Laboratories |
| Relibeta | interferon beta-1a | Multiple sclerosis | 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 | Reliance Life Sciences |
| Religrast | filgrastim | Neutropenia | Reliance Life Sciences |
| Relipoietin | epoetin alpha | Anaemia, Autologous blood transfusion, Chronic kidney failure, HIV | Reliance Life Sciences |
| Repoitin | erythropoietin | Anaemia, Chronic kidney failure | Serum Institute of India |
| RituxiRel | rituximab | Non-Hodgkin’s Lymphoma, Rheumatoid arthritis | Reliance Life Sciences |
| Rituximab | rituximab | Non-Hodgkin’s Lymphoma | Zenotech Laboratories |
| Shankinase | streptokinase | Arterial occlusions, Deep vein thrombosis, Pulmonary embolism | 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 | Shantha Biotechnics/Merieux Alliance |
| Shanpoietin | erythropoetin | Anaemia, Chronic kidney failure | Shantha Biotechnics/Merieux Alliance |
| Terifrac | teriparatide (parathyroid hormone) | Post menopausal women with osteoporosis who are at high risk for fracture | Intas Pharmaceuticals |
| Teriparatide | teriparatide (parathyroid hormone) | Post menopausal women with osteoporosis who are at high risk for fracture | Cadila Healthcare |
| Teriparatide | teriparatide (parathyroid Hormone) | Post menopausal women with osteoporosis who are at high risk for fracture | USV |
| Wepox | epoetin alfa | Anaemia, Cancer, Chronic kidney failure | Wockhardt |
| Wosulin | human insulin | Diabetes mellitus | Wockhardt |
|
Zavinex
|
interferon alfa-2b
|
Chronic hepatitis B, |
Cadila Healthcare
|
| Chronic hepatitis C | |||
| Zyrop | erythropoietin | Chronic kidney failure | Cadila Healthcare |
RA = rheumatoid arthritis, HIV = human immunodeficiency virus
About AMJEVITA™ (adalimumab-atto)
AMJEVITA is a biosimilar to Humira®* (adalimumab), an anti-TNF-α monoclonal antibody. The active ingredient of AMJEVITA is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as Humira. AMJEVITA is approved to treat seven inflammatory diseases including moderate-to-severe rheumatoid arthritis in adults, moderate-to-severe polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, psoriatic arthritis in adults, ankylosing spondylitis in adults, moderate-to-severe chronic plaque psoriasis in adults, moderate-to-severe Crohn’s disease in adults and pediatric patients 6 years of age and older and moderate-to-severe ulcerative colitis in adults.2 AMJEVITA outside the U.S. is marketed as AMGEVITA® (adalimumab) and has been prescribed to more than 300,000 patients in over 60 countries.
*Humira® is a registered trademark of AbbVie, Inc.
www.ametheushealth.com
info@ametheus.com
