By John Carroll

Will FDA officials raise the regulatory bar on biosimilars so high they can’t be competitive in the U.S.?  Longtime researcher and Parexel consultant Dr. Saurabh Aggarwal seems to think there’s a very high risk of that.

In an interview with Scientific American blogger Khadijah Britton, Aggarwal says that the FDA’s latest stab at outlining the approval process for biosimilars highlights just how complex and expensive this will be. Add in an even tougher approval process that will be needed to achieve interchangeability-the right for pharmacists to substitute a branded biologic with a biosimilar–along with increasing signs that payers and providers won’t settle for anything less, he adds, and you have a recipe for failure.

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