Text of Bio similars-scope & future prospects in india
Bio-similars: Scope & future prospects in India Under the guidance of: By : Dr. JVenkata Rao Shradha Basu Professor & HOD M.Pharm 1st year Department of Biotechnology R. No. 130610001 MCOPS MCOPS
Contents Introduction Definitions Classifications Market overview Regulatory issues Regulatory guidelines Development process in India Approval process Forces shaping the biosimilar market Factors supporting biosimilar market Biosimilar market in India Specific company advancements Conclusions
Introduction The market for biologics is growing at twice the rate of pharmaceutical drugs, placing significant cost pressures on government, employers, insurers, and patients. Establishing a regulatory pathway for follow-on biologics (bio-similars) was therefore felt to be necessary by many stake holders to encourage competition and reduce prices. Many pharmaceutical companies both large and small - are expecting their bottom line growth to be driven by bio- similars and are channelling their R&D budgets to compete in what according to many - is going to be one of the hottest areas in a radically changing global pharmaceutical market. -QPS, global CRO
Definitions According to the WHO, a bio-similar is a bio- therapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference bio- therapeutic product. According to the FDA, a bio-similar is a biological product that is highly similar to a US-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.
According to the EMA, bio-similar is a medicinal product which is similar to a biological medicinal product that has already been authorised (the biological reference medicinal product).The active substance of a bio-similar medicinal product is similar to the one of the biological reference medicinal product.The name, appearance and packaging of a bio-similar medicinal product may differ to those of the biological reference medicinal product. It may also contain different inactive ingredients. India's definition : a biological product or drug produced by genetic engineering techniques and claimed to be "similar" in terms of quality, safety, efficacy to a reference innovator product, which has been granted a marketing authorization in India by a competent authority on the basis of a complete dossier, and with a history of safe use in India.
Biologics represent one of the fastest growing segments of the pharmaceutical industry. They refer broadly to substances produced by living cells using biotechnology (i.e., recombinant DNA technology, controlled gene expression, or antibody technologies), which have introduced many new treatments to life-threatening and rare illnesses such as cancer, diabetes, anaemia, rheumatoid arthritis and multiple sclerosis. They involve a wide range of substances, including recombinant hormones, growth factors, blood products, monoclonal antibody-based products, recombinant vaccines, and advanced technology products (gene and cell therapy biological products).
Bio-similars Cytokines Interferons: INF-, INF-, INF- etc. Interleukins : IL-2, IL-3, IL-4, IL-6 etc. TNF :TNF Nucleic acid therapeutics : plasmid DNA Blood products & therapeutic enzymes : Heparin, DNase etc. Hormones of therapeutic interest : Insulin, Glucagon, hGH etc. Growth factors : IGFs, EGFs, PDGF etc. Haemopoietic growth factors : G- CSF, M-CSF, EPO etc.
Regulatory guidelines FDA ( for USA) The Patient Protection and Affordable Care Act I. Signed into law by President Obama on March 23, 2010 II. Amends the Public Health Service Act (PHS Act) III. Create an abbreviated licensure pathway for biological products that are demonstrated to be bio-similar to or interchangeable with an FDA-licensed biological product (pathway is provided as part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act).
EMEA (for Europe, Middle East,Africa ) A total of 3 guidelines First guideline I. information on similar biological medicinal products II. describes the concept of bio-similars III. the general principles to be applied in demonstrating bio- similarity IV. Revised in May 2013 Second guideline I. the quality issues related to bio-similar development II. Revised in May 2012 Third guideline I. addressing the clinical and non-clinical issues related to bio- similars containing biotechnology-derived proteins as the active substance II. addresses non-clinical and clinical requirements for marketing authorisation of a bio-similar
EMA approved bio-similars Product name Active substance Therapeutic area Authorization date Manufacturer/ Company name Abseamed epoetin alfa Anaemia Cancer Chronic kidney failure 28 Aug 2007 Medice Arzneimittel Ptter Bemfola follitropin alfa Anovulation (IVF) CHMP positive opinion 23 Jan 2014 Finox Biotech Binocrit epoetin alfa Anaemia Chronic kidney failure 28 Aug 2007 Sandoz Biograstim filgrastim Cancer Haematopoietic stem cell transplantation Neutropenia 15 Sep 2008 CT Arzneimittel Epoetin alfa Hexal epoetin alfa Anaemia Cancer Chronic kidney failure 28 Aug 2007 Hexal Filgrastim Hexal filgrastim Cancer Haematopoietic stem cell transplantation Neutropenia 6 Feb 2009 Hexal Grastofil filgrastim Neutropenia 18 Oct 2013 Apotex
CDSCO, GEAC, RCGM (for India) Drugs and Cosmetics Act,1940; Drugs and Cosmetics Rules,1945 & Rules for the manufacture, use, import, export and storage of hazardous microorganisms/genetically engineered organisms or cells,1989 Guidelines are as follows: I. Recombinant DNA Safety Guidelines, 1990 II. Guidelines and Handbook for Institutional Biosafety Committees (IBSCs), 2011 III. Guidelines for generating preclinical and clinical data for rDNA vaccines, diagnostics and other biologicals, 1999 IV. CDSCO guidance for industry, 2008:- a) Submission of Clinical Trial Application for Evaluating Safety and Efficacy b) Requirements for permission of New Drugs Approval c) Post approval changes in biological products: Quality, Safety and Efficacy Documents d) Preparation of the Quality Information for Drug Submission for New Drug Approval: Biotechnological/Biological Products
Similar biologics approved and marketed in India Product name Active substance Therapeutic area Authorization date Manufacturer AbcixiRel abciximab Angina Cardiac ischemia 23 Apr 2013 Reliance Life Sciences Alzumab itolizumab Psoriasis 27 Dec 2012 Biocon Basalog insulin glargine Diabetes 2009 Biocon Insulin insulin Diabetes mellitus 9 Aug 2011 Gland Pharma CanMab trastuzumab Breast cancer 23 Oct 2013 Biocon Filgrastim filgrastim Neutropenia 22 Oct 2013 Cadila Pharmaceutical Choriorel chorionic gonadotrophin hormone r-hCG Female infertility 22 Jun 2011 Reliance Life Sciences Intalfa interferon alpha-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 Biopharmaceuticals Cresp darbepoetin alfa Anaemia Cancer Chronic kidney failure 23 Mar 2010 Dr Reddys Laboratories
Product name Active substance Therapeutic area Authorization date Manufacturer Emgrast filgrastim Cancer Neutropenia 16 Mar 2010 Gennova Biopharmaceuticals (Emcure) 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 Biopharmaceuticals FostiRel follitropin beta (follicle stimulating hormone) Female infertility 30 Apr 2010 Reliance Life Sciences Glaritus insulin glargine Diabetes mellitus Mar 2009 Wockhardt MabTas rituximab Lymphoma Non-Hodgkins Lymphoma 26 Feb 2013 Intas Biopharmaceuticals Mirel reteplase (tissue plasminogen activator) Myocardial infarction 2009 Reliance Life Sciences M