Publications by authors named "Lisa M DiGrazia"
Purpose: The biosimilar development process, comparability for biological agents, and analytic characterization of biosimilars are described.
Summary: Healthcare providers must understand the requirements for biosimilar approval, including the science behind biosimilar development and testing that contributes to the totality of evidence. The foundation of development is to demonstrate that a biosimilar is highly similar to the reference product through analytic characterization.