Biosimilar

Definition

A biological medicine that is highly similar to an already approved reference biological product, with no clinically meaningful differences in safety, purity, or potency. Unlike generic small-molecule drugs, biosimilars cannot be exact copies due to the complexity of biological manufacturing processes and require their own clinical trials to demonstrate similarity. The biosimilar approval pathway (under the EU's 2004 framework and the US Biologics Price Competition and Innovation Act of 2009) is more rigorous and costly than generic drug approval, resulting in more modest price discounts (typically 15-35%) compared to small-molecule generics.