Biosimilars Gil Bashe 2 28 11 Final

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March 1, 2011 Biosimilar Presentation at Visiongain

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Biosimilars Gil Bashe 2 28 11 Final

  1. 1. Beyond the Regulatory Process:Creating a Market for Biosimilars Gil Bashe Executive Vice President MakovskyHealth 212.508.9672 gbashe@makovsky.com 1
  2. 2. The long-term issue for biosimilars will be marketpenetration. That is and will remain the heart of thebiosimilar challenge in Europe and in the US… as for howbiosimilars will get to patients after that: I’m not sure ifthere’s a model yet. Ronny Gal, Analyst Bernstein and Company May 19, 2009 2
  3. 3. Snapshot USLaws and Regulations Payer PerspectiveMarch 2010: biosimilars must be No „„A‟‟ rating in FDA‟s Orange Book.subject to at least one clinical trial todemonstrate safety and efficacyAnalytical studies that demonstrate Pharmacists or hospitals may notthat the biological product is highly substitute automatically a biosimilar forsimilar to the reference productnotwithstanding minor differences in brand.clinically inactive componentsFDA can determine that some of thesedata are unnecessaryAdministration route, dosage form, andbiological product strength are thesame as the reference product12 years market exclusivity toinnovator. 3
  4. 4. Snapshot EuropeLaws and Regulations Payer PerspectiveEMEA requires extensive testing Decision of interchangeability of biosimilars and innovator made byEMEA takes a case-by-case individual member statesapproach France, Spain and Netherlands banBiosimilars are required to undergo pharmacists from substituting apost-marketing monitoring just like biosimilar version if a physician hasnew innovative biologies prescribed the originalRequires “differences between thesimilar biological medicinal product UK has not banned substitution;and the reference medicinal however, has said it doesn‟t expect itproduct are justified by appropriate to occur.studies”10 years of market exclusivity forinnovator. 4
  5. 5. Different Market Dynamic From GenericsMarket Share Generics Market Share Biosimilars 5
  6. 6. Shifting Operations from Process to PatientCurrent focus of biosimilar companies is on regulatoryprocess, overcoming legal hurdles, approval,manufacturing and product distribution channelsConsider all of the day-to-day operational logistics andcreate buy-in from managed care, physicians and patients 6
  7. 7. Connecting the Confidence Continuum Patient/caregivers Government Prescribers Payers Biosimilar Conversion FDA/EMEA KTLs Specialty distribution Media 7
  8. 8. Case Study 1-rhGH The Case for Patient Support• Five patent-protected products dominate US market• FDA approves Omnitrope for US market in 2006• KOLs concern for safety and compared growth effect• Omnitrope 2007 sales - $7MM - just 0.3% of rhGH market1. No data2. No patient support services3. No comparable device vehicle 8
  9. 9. Case Study 1-rhGH• OmniSource patient support program created• Save As You Grow coupon program• Approval for two doses in pen applicators• In the US, the brand has overtaken Teva‟s Tev-Tropin as leading follow-on human growth hormone, while more than 30% of naïve patients in Europe are now being treated with Omnitrope As a company, we over-estimated the importance of price alone. Healthcare stakeholders [doctors, payers and patients] care about cost when other things are equivalent. Ameet Mallik, Global Head Sandoz Biopharmaceuticals November 22, 2010 9
  10. 10. Case Study 2 – Hospira The Case for Data • Retacrit was studied to show it is comparable with the reference medicine, Eprex/Erypo, in experimental models and in humans • Rigorous Phase III clinical trial demonstrating comparable efficacy and safety between epoetin zeta and the reference product, epoetin alfa, when administered SC in patients with end-stage renal failure on chronic haemodialysis • CHMP concluded, in accordance with EU requirements, Retacrit has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo • 12% market share in 2010 (Hospira Q4 2010 earnings call) Weve been growing faster than the market, and we really believe we can continue to grow faster than the market, I see that going on for an extended period of time. Chris Begley, CEO, Hospira September 30, 20091. Data for prescribers and payers-almost 1,000 patient years2. Clear messages on cost savings for payers3. Clear messages on government advocacy4. Patient safety and support initiatives 10
  11. 11. Biosimilar Conversations in Social Media 11
  12. 12. Elements for Brand Uptake Corporate Reputation Scientific Process Legal and Regulatory Capacity Quality GMP Regional Approval KOL/Advocacy Patient Support Services 12
  13. 13. What separates one company from the next is that we’renot treated like the customers that we are, but like actual patients. Kevin R. Kline, Patient February 17, 2009 13
  14. 14. Questions? 14
  15. 15. Gil BasheExecutive Vice President MakovskyHealth 212.508.9672gbashe@makovsky.com 15

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