US FDA completes updates for biosimilars and novel drug fee schedules as PDUFA VI is set to begin.
With less than three weeks to go before the launch of the new user fee cycle, the US FDA has officially announced the rates that sponsors of biosimilars and novel drugs will have to pay.
In announcements scheduled to be published in the Federal Register on Sept. 14, the agency set the rates for biosimilar and prescription drug applications in Fiscal...
If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
