Because the FDA could not previously approve biosimilars, only a handful of products have been developed and the industry isn’t quite sure what to expect. Drugmakers are therefore requesting meetings and consultations with agency reviewers while they’re still developing their products.
The FDA wants to begin charging user fees for those meetings because they are “where FDA activities currently are in greatest demand and increased review capacity is needed," according to a notice published Monday.
Under the existing program, brand-name drugmakers pay their user fees when they submit a finished application for the FDA to review. For biosimilars, the agency wants to collect roughly $150,000 per year during the development phase, then subtract the total of those fees from the cost of a final approval decision.