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

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FDA desire for specific innovations in biotherapeuticanalysisSteven Kozlowski, M.D.Director, Office of Biotechnology ProductsThree Specific Properties Needing Improved MeasurementFDA has identified three properties of therapeutic proteins that cannot besufficiently measured at this time but that are very important for understandingthe behavior of protein drugs. Improved analytical methods to measure these threeproperties would be particularly useful in determining the extent of similarity ofbiological protein products intended to be similar.1. Post-translation Modifications …2. Three-dimensional Structure …3. Protein Aggregation …TESTIMONY BEFORE THESUBCOMMITTEE ON TECHNOLOGY AND INNOVATIONCOMMITTEE ON SCIENCE AND TECHNOLOGYU.S. HOUSE OF REPRESENTATIVESSEPTEMBER 24, 2009
FDA desire for specific innovations in biotherapeuticanalysisSteven Kozlowski, M.D.Director, Office of Biotechnology Products1. Post-translation ModificationsAs indicated previously, proteins contain added structural features, such asattached sugar chains, that may be critical for their clinical activity. Theseattached modifications can be complex and heterogeneous, and wecurrently lack standardized analytical methods to qualitatively andquantitatively assess the structure as it relates to the intact protein andunderstand the relationship of the modifications to potency and clinicalperformance. We are particularly interested in better methods foranalyzing the sugars (glycosylation) and other modificationsknown to affect the medicinal activity of these products.TESTIMONY BEFORE THESUBCOMMITTEE ON TECHNOLOGY AND INNOVATIONCOMMITTEE ON SCIENCE AND TECHNOLOGYU.S. HOUSE OF REPRESENTATIVESSEPTEMBER 24, 2009
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 and 36: Underscoring the need for appropria
Page 37 and 38: Biologics Price Competition and Inn
Page 39: Nature Reviews Drug Discovery, 2012
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 89: Learning from History: Making Biosi

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