Learning from History: Making Biosimilars a Reality - Genetic ...
Learning from History: Making Biosimilars a Reality - Genetic ...
Learning from History: Making Biosimilars a Reality - Genetic ...
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Innovation required in both technical developmentand clinical developmentKey challengesTime &Investment• Significant expense (USD 100 - 250m)• Long time to develop (7-8 years)TechnicalDevelopment• Achieving “highly similar” to match originatormolecule profile• Matching final dosage form of originatorClinicalDevelopment• Use of novel endpoints and populations to confirmbiosimilarity (not de novo safety/efficacy)• Clinical trial design to support extrapolation acrossindications, interchangeability & commercial success10 | <strong>Genetic</strong> Engineering & Biotechnology News Webinar on <strong>Biosimilars</strong>, November 2012