One biosimilar developer is pushing FDA to address how changes to innovator biologics over time could affect biosimilar products that reference them, advocating for the agency to use comparability standards as a basis for determining biosimilarity, allow biosimilar determinations based only on one version of an innovator product if drift occurs and investigate ways to slow down innovator activities that create drift. Other sources said, however, that biologic products naturally drift over time and manufacturing improvement changes should not be prevented by FDA.

Concerns over biologic drug product drift — product changes that can occur over time as a result of manufacturing changes — are resurfacing as industry groups continue to push FDA to provide more information on how it will determine biosimilar interchangeability.

Read the article on Inside Health Policy.