While there always has been contention over the rules of the road for biosimilars, the battle lines have shifted since the Biologics Price Competition and Innovation Act was enacted as part of the Affordable Care Act. While previously the split was between innovator and generics companies, now the divide is between biosimilars manufacturers.

Those divisions were on display at a public meeting convened by FDA this month to discuss its biosimilars pathway. The meeting included discussion of two critical and contentious issues: standards for classifying a follow-on product as interchangeable with an innovator; and whether and how to allow biosimilars applications to include comparative data about innovator products that are only approved outside the U.S.