Recommendations regarding technical standards for follow-on biologics: comparability, similarity, interchangeability

AbstractBackground: Policy makers around the world are currently considering the creation of a regulatory pathway for follow-on biologics (FOB), which will have to account for the substantial technical challenges associated with FOB development. These challenges will likely involve more complexity than comparability assessments of process changes made by the same manufacturer. The history of industry–regulator comparability discussions helps explain why the same degree of testing and flexibility now applied to change-control within a manufacturer's own process, at this time, cannot be extrapolated to the observed and possibly unknown differences between two manufacturing processes that are independently developed by different (non-collaborating) parties.Objectives: This commentary provides recommendations on the technical aspects that should be considered in the creation of an approval pathway for FOB products.Conclusions: In the authors’ view, analytical methodology in its current state cannot alone prov...