Commissioner Gottlieb Addresses Biosimilars at Conference - Big Molecule Watch

At CNBC’s Healthy Returns conference last week, FDA commissioner Scott Gottlieb discussed plans to encourage competition and speed approval of biosimilars.  His comments largely tracked a statement that he made in early March.  Gottlieb again criticized arrangements between distributors, pharmacy benefit managers, and health plans, which he views as restricting market access.  In view of this, Gottlieb said that health care providers like doctors will need to play a role to help launch biosimilar drugs.  But Gottlieb warned:  “There is no silver bullet here that will make the biosimilars market go gangbusters.  It’s going to be a slow build.”

Gottlieb further stated that amongst new policy proposals under consideration was a proposal to require reference product sponsors to have less batch-to-batch variability, which Gottlieb believes could make it easier to produce biosimilar drugs.  “That drift [] makes it hard to copy those drugs,” because it represents a “moving target,” Gottlieb said.

Big Molecule Watch will continue to follow regulatory developments that impact biosimilars, so check back for the latest news and analysis.

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