Many health experts insist that biosimilars will not truly hit their upside potential until they achieve interchangeability status with the innovator product they are intended to mimic. The post below from the BioProcess Blog indicates that the EMA is still not supporting interchangeability as it contemplates its new guidelines for biosimilars.
In the post, the EMA is lauded for updating its thinking and proposed guidelines on biosimilars from its 2005 regulations -- particularly its recognition of the importance of defining reliable PK/PD markers for biosimilarity in non-clnical studies, plus the possibility of using non-inferiority as an end-point for clinical trials.
Non-inferiority should allow for faster, smaller and less expensive clinical trials, but will also likely make it harder to establish interchangeability. The current guidelines and proposed revisions do not address what it will take to establish interchangeability according to blog authors. They conclude that neither the EMA nor the FDA will likely establish a meaningful path to interchangeability in the forseeable future. Thus, biosimilars will not achieve their peak market penetration and ultimate sales potential that could be predicted with interchangeability.
Posted by Bruce Lehr Oct 31st 2011.