FDA Biosimilars Guidances Stuck in Review, But That Isn’t Stopping Progress

Drug Industry Daily
Even though the FDA hasn’t released details on how its abbreviated approval pathway for biosimilars will work, the agency has already held 21 pre-IND meetings on 11 reference biologics and received seven INDs, said Leah Christl, CDER’s associate director for biosimilars.

To View This Article:


Subscribe To Drug Industry Daily