How can Modelling and Simulation Fuel the Clinical Development of Biosimilars?
The relatively low cost to enter the “generic” market and the size of the biologic drug market make entry attractive. However, the failure rate for biosimilars is deemed high, due to the complex manufacturing process and the high variability expected for biologics. Bernardo de Miguel Lillo and Daniel Röshammar at SGS Exprimo discuss why there is a high risk-cost relationship in the establishment of clinical biosimilarity.
The full paper is available here.