Managed Healthcare Executive reports that the biosimilars market received greater regulatory clarity from the FDA in 2017 and therefore will usher in the “biosimilar era” if manufacturers can seize market share. Noted changes last year included the final rules from CMS that established unique billing codes for each biosimilar and draft guidance for establishing interchangeability. The article notes, that while no biosimilars have yet been approved as interchangeable and that’s unlikely to change in 2018, state governments will become bigger players in implementing biosimilar interchangeability, as more state legislatures weigh in on implementation of interchangeability for biosimilars prescribing.
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