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