Biosimilar User Fee Deal Called Key to Boosting Patient Access

The FDA’s next user fee agreement with biosimilar makers marks a fundamental effort to get alternatives to costly biologic drugs in the hands of patients, industry representatives said Tuesday.

Leading pharmaceutical groups met with officials from the Food and Drug Administration to discuss the latest proposal for the reauthorization of user fees for fiscal years 2023 through 2027. The plan includes agency goals of expediting biosimilar application reviews and boosting development of interchangeables—products able to be substituted for a brand-name biologic at the pharmacy counter.

Tuesday’s meeting was a key step in the process before the FDA hands off its ...