Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Biosimilars analysing market intelligence (peter wittner)


Published on

Published in: Business, Health & Medicine
  • Be the first to comment

Biosimilars analysing market intelligence (peter wittner)

  1. 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. 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. 3. What makes Biosimilars uptake more difficult than generics?Interchangeability – the big hurdle 3
  4. 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. 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. 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. 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. 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. 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. 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. 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. 12. What has happened so far?Source: Amgen Q1 ’10Earnings Call 12
  13. 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. 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. 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. 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. 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. 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. 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. 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. 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. 22. Any questions?Mail me if you think of them later 22