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

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FDA: Abbreviated clinical development feasibleSource: Steven Kozlowski, Director, Office of Biotechnology Products, Biosimilar Workshop, APEC, Seoul, April 4, 201218 | Genetic Engineering & Biotechnology News Webinar on Biosimilars, September 2012
Exaggerated expectations for Biosimilar clinical trials• Temple: “Recent biosimilar legislation calling for biosimilar products to beshown to have ‘no clinically meaningful differences’ for the reference productwill greatly extend discussion of how to determine when two treatments are‘essentially’ the same. At present, however, there is no real consensus orstandard.”• “With rare exceptions, differences between drugs, if any, will be small,considerably smaller than the whole effects of the drugs, which themselvesare often small. And the difference one would want to rule out is also small.”• If it is challenging to differentiate between two distinct therapeutic entities, itwill be even more difficult to differentiate between a biosimilar and originatoreven with minor differencesRobert Temple: Clinical Trials 201119 | Genetic Engineering & Biotechnology News Webinar on Biosimilars, September 2012
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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 17: OverviewWhy biosimilars?QbD and the
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
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Progression of Immunogenicity Testi
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Antibodies Can Cross React with Mul
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Why Conduct an Immunogenicity Asses
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Antibody Characterization: Binding
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Cell Based Assays:Product Release a
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Target Cell and Neutralizing Antibo
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Corporate OverviewIllinoisWIL Resea
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Thank YouMarie Rock, Ph.D.
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Learning from History: Making Biosi
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Learning from History: Making Biosimilars a Reality - Genetic ...

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