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

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An Open Forum on the Scientific and Regulatory Issuesof <strong>Biosimilars</strong> and Follow-on BiologicsBoston, MA USACopley Marriott Hotelwww.barnett.neu.edu/biogenerics/Address by:Senator Edward KennedyChairman of the Senate Health,Education, Labor and PensionsCommitteePlenary by:Dr. Randall LutterActing Deputy Commissionerfor Policy, US FDAA high level meeting of the international biotechnology and generics industries, togetherwith government regulators and academic laboratories, for an open forum and collegialdebate on the scientific and regulatory issues in the introduction of generic complexbiological drugs.For additional information or to receive updates, email Biogenerics2008@neu.eduOrganizing Chair:Prof. Barry KargerDirector, Barnett Institute, andJames L. Waters Chair,Northeastern UniversityHosted by:
Biologics Price Competition and Innovation Act (BPCI Act), enacted March 2010The FDA sought comments on the following issues related to determiningbiosimilarity:1. What scientific and technical factors should the agency consider indetermining whether the biological product is highly similar to the referenceproduct notwithstanding minor differences in clinically inactive components?2. What scientific and technical factors should the agency consider indetermining the appropriate analytical, animal, and clinical study or studies toassess the nature and impact of actual or potential structural differencesbetween the proposed biosimilar product and the reference product?3. What range of structural differences between a proposed biosimilarproduct and the reference product is consistent with the standard “highlysimilar” and may be acceptable in a 351(k) application if the applicant candemonstrate the absence of any clinically meaningful differences between theproposed biosimilar product and the reference product?4. Under what circumstances should the agency consider finding that animalstudies or a clinical study or studies are “unnecessary” for submission of a351(k) application?
Page 1 and 2: Learning from History: Making Biosi
Page 5 and 6: OverviewWhy biosimilars?QbD and the
Page 7 and 8: © Sandoz 2012By 2016, 7 of the top
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 19 and 20: Exaggerated expectations for Biosim
Page 21 and 22: SPR real time binding assay much mo
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: Underscoring the need for appropria
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 87 and 88:
Learning from History: Making Biosi
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Learning from History: Making Biosi
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