Published on June 15, 2013
BIOSIMILARS: ONTHEREALMOFREALITYDETERMINANTS OF SUCCESSAjaz S. Hussain, Ph.D.Chief Scientific Officer, Wockhardt Ltd.2013 AAPS National Biotechnology ConferenceBIOTEC Open Forum5/20/2013 1Ajaz S. Hussain, Ph.D.
This is my personal point of view5/20/2013 2B.Pharm.CSO VP BiopharmaceuticalsCSODeputy DirectorOffice of Pharmaceutical ScienceAssociate Professorof Pharmaceutics (tenured)Assistant Professorof PharmacyPh.D.InterdisciplinaryAjaz S. Hussain, Ph.D.
This presentation reflects my current interest• After leaving FDA my focus hasbeen on practicing QbD bycontributing to building• effective multidisciplinary teams,• business decision processes andtechnical infrastructure• To deliver, in highly uncertainbusiness environments, complexproducts and the necessaryscientific evidence• Sandoz• Biosimilars and complex generics(e.g., enoxaparin) – within aGerman/Swiss org. environment• Philip Morris International• Plant based vaccines and MRTP’s –QbD systems in a “non-pharma”sector (Swiss org. environment)• Wockhardt• Biosimilars and NCE’s – Indian org.environment5/20/2013 3Ajaz S. Hussain, Ph.D.
An information-theoretic definition: SimilaritySimilarity between Aand B may be measuredby the ratio betweenthe amount ofinformation needed tosate the commonality ofA and B and theinformation needed todescribe what A and BareA way to think about the challenges indeveloping, and communicating about,biosimilarsD. Lin (1998). http://webdocs.cs.ualberta.ca/~lindek/papers/sim.pdf5/20/2013 Ajaz S. Hussain, Ph.D. 4
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Development of Biosimilars: Determinants of Success ... challenges that need specific considerations for successful development of biosimilar products.
Quality of development and regulatory communication Design Product & process Specifications & controls Product use information Understanding Acceptable
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