Some Biosimilar User Fees Are Dropping for Fiscal Year 2026

Amidst the Trump administration’s efforts to reduce FDA and Health and Human Services Department staffing, there was concern regarding the agency’s ability to maintain its published schedule for approvals and biosimilar licensing application processing. There was hope the industry would be spared the effects of the administration’s cutbacks, because the program is largely self-funded: The … Continue reading Some Biosimilar User Fees Are Dropping for Fiscal Year 2026