Biosimilars are coming! Biosimilars are coming! in the USA and the FDA is planning to seek pharma industry input to design a set of users fees to defray costs and help expedite review of these new class of medicines.
PhRMA says it is on board with this proposal and is eager to provide input at the hearings. It is also in favor of a "science-based, separately funded regulatory program for biosimilars that is supported by appropriate dollars and user fees."
We're getting closer all the time. Now if the FDA can just issue their guidelines.
Posted by Bruce Lehr Dec 12th 2011