Anyone confusing biosimilars with small molecule generics in the U.S. has only to look at the FDA fee schedules to see a big difference between the two.
Whereas generics have their own reduced fee schedule, biosimilar sponsors pay the same fees as developers of new drugs and biologics. As a result, the fee for filing an ANDA for a new generic in fiscal 2017 will be about 3 percent of the $2,374,200 a sponsor will have to pay to file a biosimilar application, an NDA or a BLA.
Put another way, the FDA application fee alone for a biosimilar could cost as much as what it takes to develop a generic drug, which generally runs from $2 million to $5 million in R&D. (Developing a biosimilar can cost between $75 million to $250 million.)
The differences in fees for generics and biosimilars don't end with the amount of the application fee. A generics company, for instance, will pay $70,480 when it submits an ANDA for a new generic in