Original Drugs Pave the Way for Follow-on-Biologics
 

Original Drugs Pave the Way for Follow-on-Biologics

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With the impending patent expiries of biologic drugs, there is a huge market potential for subsequent entry biologics. A strong integration of R&D and marketing is key to success, and this briefing ...

With the impending patent expiries of biologic drugs, there is a huge market potential for subsequent entry biologics. A strong integration of R&D and marketing is key to success, and this briefing will highlight the technology advancements.

Why you should attend:

Learn about the growth of follow-on-biologics
Identify the drivers and restraints
Discuss trends in technology development

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Original Drugs Pave the Way for Follow-on-Biologics Original Drugs Pave the Way for Follow-on-Biologics Presentation Transcript

  • Original Biologics Pave Way for Follow-on-VersionsOriginal Biologics Pave Way for Follow-on-Versions An OverviewAn Overview Sandhya Kamath, Industry Manager Healthcare 18 June 2013 © 2013 Frost & Sullivan. All rights reserved. This document contains highly confidential information and is the sole property of Frost & Sullivan. No part of it may be circulated, quoted, copied or otherwise reproduced without the written approval of Frost & Sullivan.
  • 2 Today’s Presenter Expertise: Nine years of life-sciences expertise, which include laboratory and technology research; and consulting which comprises: •Strategic planning, building roadmaps and predictions in the research services, and mentoring a team of analysts present globally •Experience working on projects for industry sector analysis and forecast (genetics, drug discovery and clinical diagnostics), and presenting findings on industry trends and growth opportunities to audiences and clients •Leading customized projects for companies and research institutions in technology areas like stem cells, SNPs, bone-healing, enzymes, bio-informatics to name a few Years of experience: Possesses 6 years of research and consulting experience with Frost and Sullivan in monitoring and analyzing technologies in the healthcare domain. Brief work-experience in Dubai, UAE. Prior to this organization, worked in the drug-informatics domain of Jubilant. group Sandhya Kamath, Industry Manager, Healthcare Technical Insights Unit, Frost & Sullivan
  • 3 Biosimilars What’s making news? 1.Generics players and atypical brands enter the biosimilars industry 2.Partnerships and alliances continuously established for R&D (or) marketing Why the hoopla? 1.Between now and 2020, patents expire for >20 biologics 2.Enactment of legislation for approval in major regions How does it benefit the payer / patient? 1.Access to block-buster drugs at a lower cost especially in developing countries. 2.Since manufacturing costs and time to market are less than innovator product, this will translate into reduced medical expenditure ‘Similar to’ a biological drug
  • 4 Agenda Market overview Challenges Technology platforms Regulatory framework Applications Conclusion 1 3 2 4 5 6
  • 5 Market Overview Revenue forecast for the total biosimilars market globally
  • 6 Market Overview Competitive environment in biosimilars. Companies with a strong integration of marketing and R&D are likely to succeed PharmaceuticalcompaniesNewentrants GenericcompaniesContractresearch
  • 7 Challenges BiosimilarsBiosimilars Evolving regulatory environmentEvolving regulatory environment Interchangeability and biosimilar substitution Interchangeability and biosimilar substitution Slow rate of uptakeSlow rate of uptake Affordability in emerging economiesAffordability in emerging economies Brand loyaltyBrand loyalty Complex manufacturing process and high investment Complex manufacturing process and high investment The current and future scenario Current… Future…
  • 8 Technology Platforms Company Region Technology Selexis NA SUREtechnology Platform, which uses SURE CHO-M Cell line Neuclone Pty Limited Australia NeuCHO derived from the DHFR-deficient DG44 cell line, in serum-free and animal protein free media pNeu and pNeuMAB DNA vectors for high-level expression of single-chain and multi-chain proteins in NeuClone’s cell lines; NeuGRO medium to support all stages of cell line development Catalent NA GPEx technology - is a pseudo-typed, high-titer vector that generates stable mammalian cell lines Lonza EU GS Gene Expression System PanGen Biotech Korea PanGen has developed novel mammalian cell expression systems that can efficiently produce proteins from CHO cells Expression systems
  • 9 Technology Platforms Company Region Technology 3M purification technologies NA Zeta Plus™ depth filtration technology Xcellerex Inc.. Unit of GE Healthcare Life Sciences NA FlexFactory® Biomanufacturing Platform XDR™ Single-Use Bioreactors XDM QUAD Single-Use Mixing Systems Intrexon Corporation NA UltraVector® platform (Full platform for engineering, identification and purification) Cellexus Limited EU CellMaker PLUS Asahi kasei Japan Planova BioEX filters BioOptimal MF-SL Manufacturing technologies
  • 10 Regulatory Framework Not well defined pathway Regulated markets Semi-regulated markets Regional overview of biosimilar pathways. Approved biosimilars in key markets India 6 classes: EPO HGH G-CSF Monoclonal antibody Interferon Insulin India 6 classes: EPO HGH G-CSF Monoclonal antibody Interferon Insulin USA / Canada 1 Class: HGH USA / Canada 1 Class: HGH Japan 3 classes: EPO HGH G-CSF Japan 3 classes: EPO HGH G-CSF Europe 3 classes: EPO HGH G-CSF Europe 3 classes: EPO HGH G-CSF China 6 classes: EPO HGH G-CSF Monoclonal antibody Interferon Insulin China 6 classes: EPO HGH G-CSF Monoclonal antibody Interferon Insulin CEE 5 classes: EPO HGH G-CSF Interferon Insulin CEE 5 classes: EPO HGH G-CSF Interferon Insulin
  • 11 Applications  Currently biosimilar EPO, GCSF, and Growth hormones have been approved and launched in different countries  Insulin's and Monoclonal antibodies are under development and stages of approval  Cancer and Diabetes, are the therapeutic areas at the forefront This slide highlights the different types of deals in biosimilars until 2012 Year Products – patent expiry 2013 Epogen, Avonex, Byetta, Humalog, Neupogen, Rebif 2014 Remicade, Novolog 2015 Herceptin, Lantus, Neulasta, PegIntron, Rituxan, Synagis 2016 Aranesp, Humira 2017 Avastin, Pegasys
  • 12 Applications Product Class Biosimilar Product Company Therapeutic Area Active Substance Human Growth Hormone (HGH / Somatropin) Omnitrope Sandoz GmbH Dwarfism Pituitary Prader-Willi Syndrome Turner Syndrome Somatropin Valtropin BioPartners GmbH Dwarfism PituitaryTurner Syndrome Erythropoietin (EPO / Epoetin) Abseamed Medice Arzneimittel Pütter GmbH & Co. KG Anemia Cancer Chronic Kidney Failure Epoetin alfaBinocrit Sandoz GmbH Epoetin Alfa Hexal Hexal AG Retacrit Hospira UK Limited Anemia Blood Transfusion Autologous Cancer Chronic Kidney Failure Epoetin zeta Silapo Stada Arzneimittel AG Granulocyte Colony Stimulating Factor (G-CSF/ Filgrastim) Biograstim CT Arzneimittel GmbH Cancer Hematopoietic Stem Cell Transplantation Neutropenia Filgrastim Ratiograstim Ratiopharm GmbH Tevagrastim Teva Generics GmbH Filgrastim ratiopharm Ratiopharm GmbH Filgrastim Hexal Hexal AG Zarzio Sandoz GmbH Nivestim Hospira UK Ltd. European biosimilars approved and marketed
  • 13 1. New seedbanks technologies are available in the field of biotechnology, especially focused on genetic engineering and monoclonal antibody technology 2. An increasing number of companies are currently offering custom antibody services for biosimilars development 1. Flexible manufacturing/ single use systems can be fine tuned for production of biosimilars 2. Smaller bioreactors will produce similar quantities to today’s “six pack” facilities 3. Consider CMOs to outsource entire manufacturing process. Alternatively, technology licensing from companies for in-house manufacturing setup 1. Inhouse development of cell lines can be opted for since these are key to development of biosimilars 2. Technologies offering higher yield (>20g/L) and speed are available for evaluation. To reduce long-term manufacturing costs, these options can be explored 3. Choosing the right kind of license with existing biotech companies Conclusion Seed banks Cell line development Manufacturing
  • 14 Next Steps Develop Your Visionary and Innovative Skills Growth Partnership Service Share your growth thought leadership and ideas or join our GIL Global Community Join our GIL Community Newsletter Keep abreast of innovative growth opportunities Phone: 1-877- GOFROST Email: myfrost@frost.com
  • 15 Your Feedback is Important to Us Growth Forecasts? Competitive Structure? Emerging Trends? Strategic Recommendations? Other? Please inform us by “Rating” this presentation. What would you like to see from Frost & Sullivan?
  • 16 http://twitter.com/frost_sullivan Follow Frost & Sullivan on Facebook, LinkedIn, SlideShare, and Twitter http://www.facebook.com/FrostandSullivan http://www.linkedin.com/companies/4506 http://www.slideshare.net/FrostandSullivan
  • 17 For Additional Information Britni Myers Corporate Communications Healthcare (210) 477-8481 Britni.myers@frost.com Sandhya Kamath Industry Manager Healthcare (91) 80-67028001 sandhya.kamath@frost.com Nicolas Votano Sales Director Technical Insights (212)-402-1813 Nicolas.votano@frost.com