Gottlieb Flags FDA Plans to Boost Biosimilar Competition

FDA Commissioner Scott Gottlieb said the agency will issue new policies this year to help stoke biosimilar competition.

The agency’s goal for generics is to have four drugs in each category, to achieve the large reductions in drug prices that occur after the third generic drug hits the market. A drug’s average relative price per dose lowers significantly the more generic manufacturers there are, Gottlieb said.

Biosimilar approvals have climbed steadily in recent years.  The first biosimilar — Sandoz’ Zarxio, a biosimilar to Amgen’s bone marrow stimulant Neupogen (filgrastim) — was approved in 2015, followed by three approvals the next calendar year. The number increased to nine in 2017 and hit a record 16 in 2018.