Biosimilars ppt presentation

Biosimilars - Powerpoint PPT Presentation

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2. 2 UNDER THE GUIDANCE OF:- DR. SHASHIKUMAR R GUEST FACULTY DEPARTMENT OF BIOTECHNOLOGY SUBMITTED BY:- MEGHANA S Dept.of BIOTECHNOLOGY SEMINAR TOPIC ON - “BIOSIMILAR”

3. CONTENTS INTRODUCTION CURRENT STATUS TYPES OF BIOLOGICS USED IN CANCER TREATMENT BIOSIMILAR DEVELOPING PROCESS DIFFERENCE BETWEEN BIOLOGICS AND CHEMICAL MEDICINE BIOSIMILAR IN CLINICAL PRACTICES ADVANTAGES AND LIMITATIONS OF BIOSIMILAR FUTURE PERSPECTIVE OF BIOSIMILAR CONCLUSION REFERENCE 3

4. INTRODUCTION Biologics are derived from the natural resources such as human, animal, or microorganism and manufactured by various biotechnology methods such as recombinant deoxyribonucleic acid technology, controlled gene expression, and antibody technology. Biosimilar is a biologic product, which is very similar to Food and Drug Administration (FDA)-approved biological product known as reference product and has no clinically meaningful differences in term of safety and effectiveness from the reference product. 4

5. CURRENT STATUS The first biosimilar , Omnitrope (a recombinant human growth was), was approved in Europe by the European Medicines Agency (EMA) in 2006. INDIA USA EUROPE Glaritus Admelog # Abseamed Grafeel Basaglar Accofil Epofer Cyltezo Amgevita Adfar Fulphila Benepali Erbitux Herzum Bamfola 5

6. BIOLOGICS IN CANCER TREATMENT Monoclonal Antibody Cytokines Interferon (IFN), Interleukin (IL) & Hematopoietic Growth Factors Bacillus Calmette -Guerin(BCG) Vaccines 6

7. BIOSIMILAR DEVELOPING PROCESS 7

8. BIOLOGICS AND CHEMICAL MEDICINE BIOLOGICS: Generally low molecular weight Usually organic or chemical synthesis Fewer critical process steps Well-characterized Known structure Homogenous drug substance Usually not immunogenic CHEMICAL MEDICINE: Generally high molecular wieght Made wit/from live cells/organisms –inheritance and contamination risk Many critical process steps Less easily characterized Structure may or may not be completely defined or known Hetegenous mixtures – may include variants Often immunogenic 8

9. BIOSIMILARS IN CLINICAL PRACTICE Biosimilars in clinical practice: The use of biosimilars is essentially a change in clinical management.By taking a leading role in educating patients and medical professionals about the risks and benefits of biosimilars . The role of hospital pharmacists : It is of utmost importance that the hospital pharmacist is aware that the innovator products and biosimilars are not interchangeable, because patients must be carefully monitored if their treatment is changed between products. Moreover, patient welfare is foremost and for pharmacists, the knowledge that biosimilars are not generics, and the possible implications for clinical outcomes when products are switched, will help ensure patient safety.Additionally , biosimilars are deemed to contain a new active ingredient, whereas interchangeable products are not. The role of nurses in the use of biosimilars 9

10. Stages: 1. Producing the master cell line containing the gene that makes the desired protein. The genetic code (a sequence of DNA) of a selected protein (e.g. a hormone, antibody, blood product) is identified and a functional DNA sequence created. The genetic code is inserted into various host cell lines (e.g. bacteria or yeast), so that the host cells produce this protein. The host cell line that produces the protein the most successfully becomes the chosen host cell line. 2. Growing large numbers of cells that produce the protein in machines called bioreactors; this process is called fermentation. 3. Isolating and purifying the protein, separating it out of the bioreactor via a filtration process. 4. Preparing the biologic for use by patients (stabilizing and processing). 5. More patents on the process than on the drug. 10

11. 1. Producing the master cell line containing the gene that makes the desired protein. The genetic code (a sequence of DNA) of a selected protein (e.g. a hormone, antibody, blood product) is identified and a functional DNA sequence created. The genetic code is inserted into various host cell lines (e.g. bacteria or yeast), so that the host cells produce this protein. The host cell line that produces the protein the most successfully becomes the chosen host cell line. 2. Growing large numbers of cells that produce the protein in machines called bioreactors; this process is called fermentation. 3. Isolating and purifying the protein, separating it out of the bioreactor via a filtration process. 4. Preparing the biologic for use by patients (stabilizing and processing). 5. More patents on the process than on the drug 11

12. ADVANTAGES AND LIMITATIONS Advantages: Treatment cost with biosimilar is lesser than innovators biological drug. Biopharmaceuticals represent one of the fastest-growing segments of pharmaceuticals industry and by 2011, they are expected to represent 50% of the market. Patent of original product is going to expire and therefore opportunity for generic versions of biopharmaceutical is very large. The operating profit margin of traditional generic drugs is roughly 20%, but depending on the biosimilar product, profit margins have the potential to be somewhat higher, as much as 30%. Limitations: The main concerns raised regarding biosimilar are immunogenicity, efficacy, adverse effects when switching from a biologic to a biosimilar , and possible long-term effects. This issue has been well documented in two recent 2017 trials, comparing the implications of switching from an infliximab innovator to biosimilar , over the span of one year in IBD patients. 12

13. FUTURE PERSPECTIVE Many companies will have their patent expire in the forthcoming year, which will open the window of opportunity for other biopharmaceutical companies to explore the possibility of development of biosimilar products. The global market for the biosimilar is expected to grow by US$10 billion and many companies are anticipated to enter into this lucrative sector. Although the biosimilar space is still growing and evolving in the United States, India is a significantplayer in the world in manufacturing and using of biosimilars . Indian biosimilar market was approximately US$300 million in 2015. The domestic sales are close to US$250 million and growing at a compound annual growth rate of 14%. The export of biosimilar or similar biologic from India stands at a staggering US$51 million. India has the potential to become a global player in similar biologics or biosimilars 13

14. CONCLUSION Biosimilars hold promise to improve patient’s accessibility for many malignant and nonmalignant ailments by reducing the treatment cost. Since the use of the first biosimilar , the development and uses of “ biosimilars or similar biologics” have witnessed substantial growth. Every year, regulatory agencies are granting approval of various similar biologics for the treatment of many cancerous and noncancerous diseases. India has firmly established itself as a global player as a maker of similar biologics. It is also a huge market for the similar biologics because of its burgeoning population. Although the potential is high and expectation is huge for India, the challenges are also enormous and daunting to maintain the leadership. 14

15. REFERENCE Dörner  T, Kay J  Biosimilars in rheumatology: current perspectives and lessons learnt. Nat Rev Rheumatol  2015; 11 :713–24. GenericsandBiosimilars Initiative ( GaBI ). Sandoz. Sandoz biosimilar pipeline.  Rushvi P, Charmy K, Nirav C, Narendra C. Biosimilars : an emerging market opportunities in India. PharmaceutRegAffairs 2016;5:165. . Saenger P. Ten years of biosimilar recombinant human growth hormone in Europe. Drug Des DevelTher 2017;11:1505-7. 15

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