When producing a biosimilar – a generic version of an original biotherapeutic reference product (innovator) – the biosimilar’s biological potency, safety, and efficacy must be assessed during the analysis process for quality assurance purposes and to obtain approval from regulatory agencies. Using LC-MS analysis, Alphalyse has documented that some biosimilars contain fewer impurities than their originators. This knowledge has served as a quality attribute of the products and provided our clients with a significant competitive advantage.