Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance
Abstract: Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each undergo unique patterns of drift and evolution in their manufacturing processes (divergence), ultimately resulting in two products that would be no longer biosimilar. In cases […]
