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CISummit 2013: Steve Gullans & Gregory Gallo, The BioSimilar Age: How to Promote a Biosimilar and Defend a Franchise from a BioSimilar Attack
This document discusses the transition from biologics to biosimilars in the pharmaceutical industry. It notes that biosimilars face manufacturing challenges to demonstrate equivalence to their reference biologic products. While biosimilars may receive regulatory approval, concerns around their efficacy, safety and manufacturing processes could slow their adoption by physicians and patients. Marketing strategies like identifying influential prescribers and developing brand awareness will be important to maximize the successful utilization of biosimilars.
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CISummit 2013: Steve Gullans & Gregory Gallo, The BioSimilar Age: How to Promote a Biosimilar and Defend a Franchise from a BioSimilar Attack
- 1. The Biosimilar Age:Adoption, Perceptions and Implications for Marketing Steve Gullans and Gregory Gallo 617.558.0210 | info@activatenetworks.net | www.activatenetworks.net 1 Newton Executive Park, Suite 100 | Newton, MA 02462
- 2. What does thatmean? Not a Brand…. Not a Generic.. It’s a Biosimilar! © 2013 Activate Networks 2
- 3. Transition from Biologicsto Biosimilars Today in U.S. © 2013 Activate Networks 3
- 4. In the BullsEye © 2013 Activate Networks 4
- 5. Biologics Patent Cliff http://www.mdpi.com/1424-8247/5/12/1393 ©2013 Activate Networks 5
- 6. Major Biosimilars inDevelopment 2012 Sales $Billions Total in Development Rituxan/Mabthera $ 6.45 22 Enbrel $ 7.97 17 Neuogen $ 1.26 14 Neulasta $ 4.09 12 Epogen $ 3.40 10 Herceptin $ 6.15 9 Avastin $ 5.54 8 Aranesp $ 2.70 7 Humira $ 9.26 7 NovoSeven $ 1.54 5 Reference Product http://www.firstwordpharma.com/node/1118043#axzz2fSPfYLQL © 2013 Activate Networks 6
- 7. Transition from Biologicsto Biosimilars Future © 2013 Activate Networks 7
- 8. Slow Start withGreat Potential 2010 sales: $250 million 2017 sales: Estimated $3.9 billion © 2013 Activate Networks 8
- 9. Low Price Isthe Driver Relative Price (%) 100 -20-30% 75 50 -50-80% 25 0 Brand Drug Generic Biologic Biosimilar © 2013 Activate Networks 9
- 10. But…. Concerns and Issues: •Efficacy and equivalence • Safety • Manufacturing • Regulatory approval process in U.S. • Adoption ― Substitution ― Initiation ― Interchangeability © 2013 Activate Networks 10
- 11. Product/Manufacturing Challenge EPO Brazil– Case Study of A Biosimilar • Analyzed 12 Biosimilar Epoetins from 5 manufacturers • Potency varied 68% to 119% of label • Isoform variations observed • Bacterial endotoxins found in 3 products1 • Brazil Regulatory suspended import of 2 epoetins2,3 1Schmidt, CA et al. Arq Bras Endocrinol Metabol, 2003: 47, 183. 2 http://e-legis.bvs.br/leisref/public/showAct.php?id=9210 3 http://e-legis.bvs.br/leisref/public/showAct.php?id=8151 © 2013 Activate Networks 11
- 12. Price Matters… • Pricesensitivity is different for new vs. existing patients Price Reductions Required to Mandate Biosimilar Use New Patient Existing Patient © 2013 Activate Networks 12
- 13. EU Biosimilar UseIncreasing - Adoption varies by Country http://www.sec.gov/Archives/edgar/data/310158/000095012311097292/y93336exv99w1.htm © 2013 Activate Networks 13
- 14. Will We ReallyTrust a Look Alike? © 2013 Activate Networks 14
- 15. Auto Industry Analog Brands Generics Biosimilars ©2013 Activate Networks 15
- 16. Evolution in thePharmaceutical Industry Brands Generics Biosimilars ? ? © 2013 Activate Networks 16
- 17. Back to WhereWe Started… • Is it a generic? • Is it a brand? • Or somewhere in between? More important, how can you optimize resources to defend or if you’re launching a biosimilar, succeed? © 2013 Activate Networks 17
- 18. Attaining Success inBiosimilars • Which companies will successfully navigate: ― Manufacturing costs higher than generics ― Price competitiveness with brands will not be as big an advantage ― Promotion & Education • HCP’s and Patients – Physician access – Multi channel resources but limitations • Developing a “brand” identity • Payer relations © 2013 Activate Networks 18
- 19. Maximizing Investments and AvailableResources Identify essential HCP’s with outsized influence • Identify physicians with central role in network and their connections • Target more efficiently • Accelerate knowledge flows • Drive behavior faster and more efficiently © 2013 Activate Networks 19
- 20. Prescribers of Statins,2009 Adopting Crestor + Generics © 2013 Activate Networks 20
- 21. Prescribers of Statins,2012 Adopting Crestor + Generics © 2013 Activate Networks 21
- 22. Change in MarketShare - Following Introduction of Alternatives Lipitor Crestor Generics © 2013 Activate Networks 22
- 23. Market Performance Variesby Community of Practice Trend Lines ~ Blue- Lipitor ~ Yellow- Crestor ~ Green- Generic © 2013 Activate Networks 23
- 24. Influencers Make theDifference - Loyalty to Lipitor January 2012 January 2009 months One central key influencer stays loyal to Lipitor Community remains loyal More market share retained by Lipitor © 2013 Activate Networks 24
- 25. Influencers Make theDifference - Rapid Adoption of Alternatives January 2012 January 2009 months Key influencers are early adopters of Crestor or generics Most of the community switches to Crestor or generics © 2013 Activate Networks 25
- 26. Case Study: Early Adoptersvs. Influencers Months Since Launch 5 24 Few adopters in this Early Adopter is not cluster due to a lack influential in cluster of influential earlyadopters Influential Early Early Adopter isin Adopters result highly connected widespread and is highly adoption in this influential in cluster cluster © 2013 Activate Networks 26
- 27. Factors Impacting PatientAccess Interchangeability • Approval path • Patient’s ability to switch Prescriber Confidence Price Difference • Comfort with new patients • Expect small price difference in US like the EU • Willingness to switch patients • Fewer payer mandates Payer Requirements Product & Manufacturing • Reimbursement restrictions • Efficacy / safety • Costs, QC • Coverage restrictions • Patient co-pay • Post-market surveillance © 2013 Activate Networks 27
- 28. Patients Will HaveQuestions … “Is this medicine really the same?” “Are you sure the FDA approved this?” “Bio-what?” Gee, I’ve never heard of Ponzi Pharmaceuticals.” © 2013 Activate Networks 28
- 29. Branding of Therapeutics ©2013 Activate Networks 29
- 30. Social Networks forBranding • Facebook, Twitter, etc. © 2013 Activate Networks 30
- 31. Monitoring Brand Awareness “NameDropper” Game • Addictive • Word association • Prompt with relevant and irrelevant words • Thousands of people • Known demographics © 2013 Activate Networks 31
- 32. Nexium vs. Abilify -Awareness of Drug’s Purpose Heartburn Depression © 2013 Activate Networks 32
- 33. Nexium vs. Abilify: -Brand Awareness © 2013 Activate Networks 33
- 34. Nexium vs. Abilify -Attributes Effective Miracle cure Nausea Addictive Effective Life saver Sleep Addictive © 2013 Activate Networks 34
- 35. Takeaways • Don’t belulled by slow start in the US ― Market potential is great • Multiple barriers will raise the game for everyone • Efficient resource utilization will be critical ― Development & approval ― Promotion and marketing • Just like advances in the science of drug development, advances in optimizing promotion resources will need to deployed to achieve success © 2013 Activate Networks 35
Editor's Notes
- #23 The overall pattern of Market Share changes during this time is a decline in the use of Lipitor, but with it remaining the dominant StatinCrestor and Other Statins steadily gained market share, but they were much more successful in certain communities of the networkDeviations from these market share values in small areas of the network can be triggered by influential physicians and their behaviors
- #28 NEW SLIDE