DMARDs are Disease modifying Antirheumatic drugs that halt disease progression and prevent further joint damage in rheumatic disorders. Currently available treatment options include NSAIDs and Steroids for symptomatic relief. Available from: 3.Arthritis and disorders of the musculoskeletal system are among the most common chronic disorders that have a huge impact on quality of life and are the leading cause of disability worldwide. India releases draft ‘similar biologic’ guidelines. ![]() GaBI Online - Generics and Biosimilars Initiative. ![]() ![]() Joshi SR, Biosimilar peptides: need for pharmacovigilance. Standards for biosimilars or ‘alternative’ biologicals in Indiaġ. 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. 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. If you have information to update Table 1, please send us your data here. India’s list of approved and marketed ‘similar biologics’ is constantly changing. Source: CDSCO (Central Drugs Standard Control Organization) ** 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. * Where brand-name is not known active substance name is given Post menopausal women with osteoporosis who are at high risk for fracture Non-Hodgkin’s Lymphoma, Rheumatoid arthritisĪrterial occlusions, Deep vein thrombosis, Pulmonary embolismīCR-ABL positive, Carcinoid Tumour, Chronic hepatitis B, Chronic hepatitis C, Chro,nic myelogenous leukaemia, Follicular lymphoma, Hairy cell leukaemia, Melanoma, Multiple myeloma Leukaemia, Lymphoma, Rheumatoid arthritisīCR-ABL positive, Carcinoid tumour, Chronic hepatitis B, Chronic hepatitis C, Chronic myelogenous leukaemia, Follicular lymphoma, Hairy cell leukaemia, Melanoma Multiple myelomaĪnaemia, Autologous blood transfusion, Chronic kidney failure, HIV Wet macular degeneration, Macular edema, Degenerative myopia, Diabetes complications Pegylated recombinant human interferon alfa 2b Recombinant human granulocyte macrophage colony stimulating factor (molgramostim)Īcute myocardial infarction, Deep venous thrombosis, Acute pulmonary embolism Metastatic colorectal cancer, lung cancer, kidney cancer, cervical cancer, ovarian cancer, brain cancers ![]() Neutropenia, Hematopoietic stem cell transplantation, CancerĪnkylosing spondylitis, Crohn’s disease, Psoriasis, Psoriatic arthritis, Rheumatoid arthritis, Ulcerative colitisĪnkylosing spondylitis, Juvenile idiopathic arthritis Psoriasis, Psoriatic arthritis, Rheumatoid arthritisĬarcinoid tumour, Chronic hepatitis B, Chronic hepatitis C, Hairy cell leukaemia, Chronic myelogenous leukaemia, BCR-ABL positive, Follicular lymphoma, Malignant melanoma, Multiple myeloma Table 1: ‘Similar biologics’ approved and marketed in India Product name*Īnkylosing spondylitis, Plaque psoriasis, Psoriatic arthritis, Rheumatoid arthritis, Ulcerative colitisĪnkylosing spondylitis, Rheumatoid arthritis, Psoriatic arthritis, Psoriasis, Juvenile rheumatoid arthritisĬancer, Hematopoietic stem cell transplantation, Neutropeniaįollitropin alfa (follicle stimulating hormone)įemale infertility, Spermatogenesis in menįollitropin beta (follicle stimulating hormone) In recent years over 50 biopharmaceutical products have been approved for marketing in India, with more than half of them being ‘similar biologics’, see Table 1. According to our research at GaBI Online, the first ‘similar biologic’ was approved and marketed in India for a hepatitis B vaccine in 2000. India has, by far, demonstrated the greatest acceptance of ‘similar biologics’. 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). These guidelines were then revised and updated, with new guidelines, which came into effect in August 2016. 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. Finalized guidelines were implemented on 15 September 2012. India announced the release of draft regulatory guidelines for ‘similar biologics’ at the BIO industry conference in Boston, USA, on 19 June 2012.
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