The advent of biosimilars: challenges and risks

Biosimilars represent a new class of medicinal products that will have significant impact on clinical use. They are identical on an amino acid sequence level to existing reference biopharmaceutical products (originals). However, they may exhibit differences on a protein level. This paper provides a brief overview of biosimilar development and describes the risk and challenges that should be considered during the admission of biosimilars into the clinic. Key words: biosimilars; monoclonal antibodies; manufacturing process; extrapolation; interchangeability; switching; Swissmedic; approval process