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Basics on Biosimilars...

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  2. 2. BIO - PHARMACEUTICALS Biological / Biotech Therapeutic Drugs Produced in Living Organism Using genetic engineering-r DNA technology Replace or supplement natural Protein produced by the body like insulin BIOTHERAPEUTICS CONVENTIONAL DRUGS Manufacturing Process Complex Biological Process Chemical Synthesis Mol. Weight 5000-200,000 Daltons 10-1000 Daltons Structure and Complexity Complex Spatial Structures Simpler Structures Cost High Relatively Low
  3. 3. BIO - SIMILARS Legally approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent & exclusivity expiry of the innovator product. Name Country Definition Similar biologics INDIA Similar in terms of safety, efficacy and quality to a reference biologic, which has been granted a marketing authorization in India SBP (Similar Biologic Product) WHO Similar to an already licensed reference biotherapeutic product in terms of quality, safety & efficacy FOB (Follow-On Biologic) US-FDA Highly similar to the reference product without clinically meaningful differences in safety, purity and potency SEB (Subsequent Entry Biologic) CANADA Drug that enters the market subsequent to a version previously authorized in Canada with demonstrated similarity to a reference biologic drug • It should be a biologic product • The reference product should be an already licensed biologic product • The demonstration of high similarity in safety, quality & efficacy is necessary
  4. 4. SIMILAR NOT IDENTICAL • Manufacturers have access to the Final Product Only • Process Details for the production of Reference Product are not available • Each Manufacturer designs their own process based on: • Different CELL LINES • Different PROCESS STEPS Biosimilars are Similar… …Not Identical CAN WE REFFER BIOSIMILARS AS BIOGENERICS? • In Theory Yes We can • But due to structural & manufacturing complexities, these biological products are considered as similar, but not generic equivalents of innovator biopharmaceuticals
  5. 5. GLOBAL SCENARIO • In 2010, sales of biologics were around $100 billion worldwide with the top 12 biologics generating $30 billion • More than 200 Biologics are already in market • By 2015, biologics responsible for $ 80 billion in annual sales will go off patent • Global market for biosimilars was $311 million in 2010 & expected to increase to $ 10 billion in 2015 Patent Expiration Dates of Some Biologics Biologic INN Name US Expiration EP Expiration HUMANIZED ANTIBODIES Avastin Bevacizumab 2019 2022 Herceptin Transtuzumab 2019 2014 Humira Adalimumab 2016 2018 Synagis Palivizumab 2015 2015 NON HUMANIZED ANTIBODIES Erbitux Cetuximab 2016 2014 Remicade Infliximab 2018 2015 Rituxan Rituximab 2018 Expired NON ANTIBODY MOLECULES Enbrel Etarnacept 2028 2015 Epogen/Epex Epoetin alfa Expired Expired Neupogen Filgrastin Expired Expired Lantus Insulin 2014 2014 Levenox Enoxaparin Expired Expired
  6. 6. REGULATORY ASPECTS • Different from Novel Biologics • Dynamic and complex nature of the global Biosimilars industry • Lack of a uniform set of standards for approval Divergent Interest Complex Molecules Uncertain Long Term Impact EVOLVING GLOBAL REGULATORY ENVIRONMENT • The First Market, Guidelines In 2005 • Largest biosimilars market in the world with robust guidelines • In 2009, Guidelines for Evaluation of Similar Bio- therapeutic Products •In 2012, DBT released a guideline for similar Biologics • In 2014, FDA released a draft guideline for similar Biologics EUROPEAN UNION (EMEA) WHO INDIA-DBT USA FDA
  7. 7. INDIAN SCENARIO • India is one of the leading contributors in the world Biosimilar market (Potential to replicate success of Indian Generic Industry) • In 2000, the first “similar biologic” was approved and marketed in India for a hepatitis B vaccine • In recent years, over 50 biopharmaceutical products have been approved for marketing in India, with more than half of them being “similar biologics”. Product Name Active Substance Therapeutic Areas Company Alzumab Itolizumab Psorasis Biocon Basalog Insulin glargine Diabetes Biocon Biomab EGFR Nimotuzumab Head and Neck Cancer Biocon CanMab Trastuzumab Breast Cancer Biocon Grafeel Filgrasim Cancer Dr. Reddy’s Lab Insugen Human Insulin Diabetes Biocon MabTas Rituximab Lymphoma Intas Pharma Nufil Filgrastim Cancer Biocon Filgrastim Filgrastim Cancer Lupin Peg-filgrastim Pegfilgrastim Cancer Lupin Peg grafeel Pegfilgrastim Cancer Dr. Reddy’s Lab Reditux Rituximab Lymphoma Dr. Reddy’s Lab Relibeta Interferon beta Multiple Sclerosis Reliance Life Sciences Religrast Filgrastim Cancer Reliance Life Sciences Rituximab Rituximab Non-Hodgkin’s lymphoma Zenotech Laboteries
  8. 8. INDIAN PLAYERS IN BIOSIMILARS • Indian companies enjoy lower facility and development costs than peers in developed countries • Repeat successes achieved in small molecule generics by partnering with larger multinational corporations (MNCs) for clinical trials, regulatory approval process in the EU / US and marketing to physicians / consumers.
  9. 9. BIOSIMILARS INDUSTRY GROWTH DRIVERS These Drivers apply in Common to both the Global as well as the Indian Market
  10. 10. BIOSIMILARS IMPORTANCE TO INDIA BENEFITS TO INDIA Benefits to Patient Population Commercial/ Industrial Benefits • India is a Developing country very few people today have health insurance. • Approximately 70% of Indians pay for health care expenses out of their own pockets and this is one of the important causes of poverty in the country • Making the medication affordable • Accessible to all sections of Society • Shorter time to market than originator products India has inherited advantages of: • Cost effective manufacturing • Highly skilled, reasonably priced workforce • Huge market • Higher probability of Return on Investment (ROI) than with new product •For instance, European Generic Medicines Agency estimated that biosimilars generated annual savings of € ∼ 1.4 billion in EU in 2009 Active Substance Trade Name Company Price (INR) Insulin Glargine (100 IU x 1 mL x 10ml) Lantus Sanofi Aventis 2530 Basalog Biocon 1475
  11. 11. CHALLENGES REGULATORY AND LEGISLATIVE CHALLENGES QUALITY AND SAFETY CONSIDERATIONS COST CONSIDERATIONS • Indian produced Biosimilars do not have the same credibility as international competitors • Reluctance from physicians to prescribe and use biosimilars • Concerns regarding their efficacy, long-term safety & immunogenicity • Regulated Markets: Strict regulations and expensive clinical trials, as well as relatively new approval processes • Semi & Unregulated Markets: approval path is unpredictable, sometimes increasing costs and process complexities • Limited guarantee of return on investment. • High Cost for development • Time consuming process (it can take 8- 10 years) and time to market is very critical COPYING IS EASY ??
  12. 12. REFERENCES • Formula of success Emerging trends in Biosimilars in India, IBEF, • Guidelines on similar biologics, DBT India, 2012 • An Overview of Biosimilars and the Biosimilar Pathway in India,, 2014