Biopharmaceuticals are much more complex than small-molecule drugs, which raises challenging questions for the development and regulatory evaluation of follow-on versions (also known as biosimilars). Jones and colleagues discuss the current state of the art in analytical technologies to assess three characteristics of protein biopharmaceuticals that regulatory authorities have identified as being important for biosimilars: post-translational modifications, three-dimensional structures and protein aggregation.
- Steven A. Berkowitz
- John R. Engen
- Graham B. Jones
