Learning from History: Making Biosimilars a Reality - Genetic ...

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Growing demand drives costs… and threatens tolimit patient access (US example)Estimated daily treatment costs 1in USD per day22The “Biologics Boondoggle”“A breast cancer patient’s annual costfor Herceptin is $37,000…1Small moleculedrugsBiopharmaceuticalsPeople with rheumatoid arthritis orCrohn’s disease spend $50,000 a yearon Humira……and those who take Cerezyme to treatGaucher disease….spend a staggering$200,000 a year…“…the top six biologics already consume43% of the drug budget for MedicarePart B”1Source: NY Times, March 2010All trademarks are the property of their respective owners.6 | Genetic Engineering & Biotechnology News Webinar on Biosimilars, November 2012
© Sandoz 2012By 2016, 7 of the top 10 pharmaceuticalsworldwide will be biologics 1ProductType2016 Rev.(USD bn)1. HUMIRA Biologic 11.2 8.32. ENBREL Biologic 7.5 7.93. RITUXAN Biologic 7.4 7.14. AVASTIN Biologic 7.2 6.05. REMICADE Biologic 7.0 7.26. SERETIDE/ADVAIR Respiratory / device 6.8 8.17. HERCEPTIN Biologic 6.3 5.98. REVLIMID Small molecule 5.9 3.29. CRESTOR Small molecule 5.8 7.110. LANTUS Biologic 5.5 5.52011 Rev.(USD bn)1Source: Evaluate Pharma March 20 2012, vaccines excludedNote: All trademarks are the property of their respective owners.7 | Genetic Engineering & Biotechnology News Webinar on Biosimilars, November 2012
Page 1 and 2: Learning from History: Making Biosi
Page 5: OverviewWhy biosimilars?QbD and the
Page 9 and 10: Biologics are more complex than sma
Page 11 and 12: Biosimilars must be systematically
Page 13 and 14: QbD biosimilar product specificatio
Page 15 and 16: Fingerprint mAbs/Fusion proteins as
Page 17 and 18: OverviewWhy biosimilars?QbD and the
Page 19 and 20: Exaggerated expectations for Biosim
Page 21 and 22: SPR real time binding assay much mo
Page 23 and 24: OverviewWhy biosimilars?QbD and the
Page 25 and 26: UK example:Biosimilars expand acces
Page 27 and 28: Analytical Characterization of Biop
Page 29 and 30: Amino acids ->peptides->proteins->P
Page 31 and 32: Tissue PlasminogenActivator [tPA]:
Page 33 and 34: Role of appropriate due diligence s
Page 35 and 36: Underscoring the need for appropria
Page 37 and 38: Biologics Price Competition and Inn
Page 39 and 40: Nature Reviews Drug Discovery, 2012
Page 41 and 42: FDA desire for specific innovations
Page 43 and 44: Differences in Sites of Fucosylatio
Page 45 and 46: ETD to analyze formation of isoAsp
Page 47 and 48: High order structures ofvery comple
Page 49 and 50: Ability to assign structural change
Page 51 and 52: Nature Reviews Drug Discovery, 2012
Page 53 and 54: size exclusionchromatography (SEC)a
Page 57 and 58:
Are the Molecules Similaror are The
Page 59 and 60:
Focus of GuidanceQualityScientificS
Page 61 and 62:
A Stepwise Approach to Demonstratin
Page 63 and 64:
Our Focus: PK & Immunogenicity•Ou
Page 65 and 66:
Typical ELISA Method for PK Determi
Page 67 and 68:
Best Practice for Side by SideCompa
Page 69 and 70:
Progression of Immunogenicity Testi
Page 71 and 72:
Antibodies Can Cross React with Mul
Page 73 and 74:
Why Conduct an Immunogenicity Asses
Page 75 and 76:
Antibody Characterization: Binding
Page 77 and 78:
Cell Based Assays:Product Release a
Page 79 and 80:
Target Cell and Neutralizing Antibo
Page 81 and 82:
Corporate OverviewIllinoisWIL Resea
Page 83 and 84:
Thank YouMarie Rock, Ph.D.
Page 85 and 86:
Learning from History: Making Biosi
Page 87 and 88:
Page 89:
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