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

Residual uncertainty decreasesOverview of FDA Approach to BiosimilarityTotality of evidence, stepwise, and risk based approachClinicalScope and magnitude depends on extent ofresidual uncertainty from below steps- No need to independently establish safety or efficacy- Immunogenicity data is minimally expectedPK/PDPK and PD (where there is a relevant PD measure)studies are generally expectedPreclinicalFlexibility regarding need for animal studies- Animal toxicity studies may not be warranted- Useful if safety uncertainties remain before first-inmanstudiesBiologicalcharacterizationPhysicochemicalcharacterizationAnalytical characterization is the foundation- The more comprehensive and robust the data, thestronger the justification for selective and targetedapproach to animal and human testingUnderstanding of reference product is important:MOA, SAR, clinical knowledge, availability of clinicallyrelevant PD measure, etc.16 | Genetic Engineering & Biotechnology News Webinar on Biosimilars, September 2012