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Biosimilars - analysing market intelligence (Peter Wittner)

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  • 1. Analysing the market CPhI Worldwide Pre-Show Conference CPhI Paris 4th October 2010 Peter Wittner Interpharm ConsultancyBiosimilars - will they be worth the effort? 1
  • 2. Analysing the market Understanding what makes Biosimilars uptake more difficult than generics  Interchangeability – the big hurdle What is the size of the pie? Analysing growth statistics and explaining the gap in performance versus potential  Biotech market is booming but Biosimilars are lagging behind Identifying the key therapeutic areas for Biosimilars  Do the numbers tell us the whole story? Where are the future opportunities for greatest growth?  US, EU or India?  Where should you invest? 2
  • 3. What makes Biosimilars uptake more difficult than generics?Interchangeability – the big hurdle 3
  • 4. What is the size of the pie? i lar sim ce io l i B sHow big will the Biosimilars slice be? 4
  • 5. What is the size of the pie?Leading Biological products 2009 2009 2008 Brand Generic Company Sales SalesEnbrel Etanercept Amgen / Wyeth $6,580 $6,490Remicade Infliximab Centocor / Schering Plough $5,934 $5,335Avastin Bevacizumab Genenetech / Roche $5,777 $4,484 Genenetech / Roche /Rituxan / MabThera Rituximab Biogen-IDEC $5,653 $5,099Humira Pen Adalimumab Abbott / Eisai $5,488 $4,521 Amgen / Ortho / Janssen-Epogen / Procrit / ESPO Epoetin Alpha Cilag / Kyowa Hakko $5,033 $5,123Herceptin Trastuzumab Genentech / Roche / Chugai $4,890 $4,384Lantus Insulin glargine Sanofi-Aventis $4,185 $3,130Neulasta Pegfilgrastim Amgen $3,355 $3,318Aranesp Darbopoetin Amgen / Kyowa Hakko $2,871 $3,334 +10%Source: La Merie report – Top 20 Biologics 2009 $49,766 $45,218 5
  • 6. What is the size of the pie?Biotech market value is mainly concentrated in Western markets............ Biological products 2009$5.0 Sales in $b n. Source: IMS Europe$4.5 US$4.0 $2.0 $1.4 $1.5$3.5 $2.0 $1.6 $1.5$3.0 $1.0$2.5$2.0$1.5 $3.0 $3.0 $2.8 $2.6 $2.5 $2.4 $2.3$1.0$0.5$0.0 Enbrel Remicade Avastin Humira Lovenox Mabthera Lantus 6
  • 7. What is the size of the pie?.... but most of world population and the Biosimilar consumer base is in low-cost developing markets W orld population breakdown 14.8% 0.5% 8.7% 5.0% 3.1% 11.9% 56.0% A frica A sia E uro p e M iddle E ast N o rt h A m erica L at in A m erica Ocean ia / A ust ralia /Caribbean 7
  • 8. Why is the biological market growing? Big Pharma is moving up market  Biologicals are higher priced than small molecule medicines  Biologicals are harder to copy = technological barrier Biologicals pricing – some US figures from GPhA  In the US the lung cancer drug Avastin costs about $100,000 per patient per year  The cost for Cerezyme used to treat Gaucher disease, can run to $300,000 / patient / year  Projected savings are between $42- $108 bn over the first 10 years of a US Biosimilar market 8
  • 9. What makes Biosimilars uptake more difficult than generics?Let’s compare with normal genericsLook at what will certainly happen with Atorvastatin  The SPC expires November 2011  Based on precedent, around 20 companies will launch on the day after the expiry  All will have been accepted as “essentially similar” to Lipitor by the regulators  All can therefore be substituted in place of the original brand and each otherIn other words, there is complete interchangeability 9
  • 10. Interchangeability – why is it an issue? Marketing biosimilars is not the same as marketing generics The big issue is interchangeability Or perhaps the real issue is the lack of it Prescribers need to be convinced that A = B or else they will not substitute when prescribing If Biosimilars cannot be prescribed by INN name, the pharmacist cannot substitute 10
  • 11. What makes Biosimilars uptake more difficult than generics?Interchangeability – experience in EU markets shows that prescribers are reluctant to switch  Most EU countries require prescription of biological products by brand name  Prescribers are therefore waiting until they see a newly diagnosed patient before trying BiosimilarResult – very slow market penetration by BiosimilarsAmgen claims it has only lost 3% MS to Filgrastim (G-CSF) copies 11
  • 12. What has happened so far?Source: Amgen Q1 ’10Earnings Call 12
  • 13. What has happened so far?“Bringing a Biosimilar to market takes upto eight years, with development costsaveraging $100-$150 million.Last year, sales of biosimilars reached just$75 million worldwide compared with$110 billion in sales of biologic drugs”Greg Perry, EGA, speaking at 8th EGA International Symposium on BiosimilarMedicines, 2nd September 2010 reported by Pharma Times 13
  • 14. Biosimilars marketplace Who will be the major players? In Western markets.....  Only companies with deep pockets!  Biosimilars have to be marketed, not just sold  That means Teva, Sandoz, Hospira In Eastern and emerging markets  The barriers to entry are lower  The market is more a classic generic market - PRICE!  Ranbaxy, Dr. Reddys, Biocon are already there 14
  • 15. Biosimilars marketplaceIt is not just the generic companies that are thinking about entering the market  2008 – Merck & Co announces plans for unit to copy biotech medicines. Aim is to sell at least six biogenerics by 2017  2009 – Eli Lilly acquires Imclone Systems and announces initiative to develop biosimilars  2009 – AstraZeneca says it is considering participation in biosimilars market  Jan 2010 – Pfizer says it plans to launch biosimilars of leading 10–15 biologicals 15
  • 16. Biosimilars – Big PharmaPfizer wants to enter China using locally made copy biologicals with Pfizer / Wyeth brandGSK will buy biosimilars from Biocon (India) for Pharmerging marketsSanofi-Aventis is also planning to target Pharmerging markets with BiosimilarsBayer-Schering is selling Gensulin from Bioton (Poland) and Insugen from Biocon in China 16
  • 17. Key therapeutic areas for BiosimilarsThis is another area where market figures alone will not be a good guideMarket data seems to show MAbs taking a growing market share But what data will the regulators want to allow you to register your copy?  The rate limiting step in regulated markets is going to be the need for regulators to provide guidelines 17
  • 18. Where are the future opportunities for greatest growth?US, EU or India?  US biological prices are under pressure but should stay highEU – price competition is growing  More Biosimilars entering the market and slow uptake will inevitably push prices downIndia – low prices  But market entry is easier and volumes are hugeWhere should you invest? 18
  • 19. Asian markets – India Changes in G-CSF (Filgrastim) prices in response to competition 6,000 5,000 4,000R Inno vato ru Bio similarpe 3,000es 2,000 1,000 0 2002 2003 2004 2005 2006 2007 2008 Source: Biocon presentation, Biosimilars India 2009 19
  • 20. Asian markets – India Comparing Indian Biological prices to the rest of the world Substance Average Average Differential world price Indian price in % Human Insulin U$ / 100 IU vial US$6.50 / 100 IU vial 80% Anti-EFGR $25,000 per $6,000 per Monoclonal treatment treatment 75% Recombinant streptokinase $150 / vial $10 / vial 95% EPO $200 / 2,000 IU $10 / 2,000 IU 95%Source: Biocon (Biosimilars India 2009) 20
  • 21. Where are the future opportunities for greatest growth?So where should you invest?India / Asia / Latin America for quick returns  Market entry is quicker and cheaper, prices are lower, but compensation is the high volumesEU/USA for longer term stability and higher margins  Market entry is slower and much more costly, but the compensation will be long-term stability and higher prices 21
  • 22. Any questions?Mail me if you think of them later peter@interpharm-consultancy.co.uk 22