FDA: A defined biosimlar pathway is coming—soon
- Although there is still no defined approval pathway for biosimilars in the U.S., two applications for biosimilars have been submitted. But Sally Howard, deputy commissioner for policy planning and legislation at the FDA, is emphasizing that a biosimilar can still be approved despite the lack of a formal pathway.
- Both applications for biosimilars submitted to the FDA, Zarzio (biosimilar of Neupogen) and Remsima (biosimilar of Remicade) were submitted in summer 2014. Both manufacturers, Sandoz (Zarzio) and Celltrion (Remsima), are awaiting an FDA decision.
- The major incentive for all stakeholders (excluding the original manufacturers) is the anticipated cost-savings associated with biosimilars, which are expected to be in the 30% to 50% range.
Unlike other parts of the world, including the EU and India, there is no fully defined pathway for approval of biosimilars in the U.S., as BioPharma Dive reported on in depth back in August.
But some things are clear. For instance, companies developing biosimlars must provide data showing that its biosimilar therapy can compete with the quality, safety, and efficacy of the original version of the drug. There are many lingering issues, however, including naming conventions, labeling, and the definition of interchangeability. Behind the scenes, the FDA is hard at work addressing these issues.