The U.S. Food and Drug Administration (FDA) has confirmed an increase of $370,000 for the review fee (PDUFA fee) charged for new drug (prescription drug) approval applications, raising it to $4,682,003 (approximately 650 million won) starting in October.
The expense is applied when submitting a new drug application (NDA) or a biologics license application (BLA) targeted at prescription drugs, which must be paid directly to the FDA by the pharmaceutical company.
According to the Korea Bio Association on 5th, the U.S. Food and Drug Administration (FDA) has finalized the review fees for the fiscal year 2026 charged to new drugs (prescription drugs), generics (synthetic drug copies), biosimilars (biologic drug copies), and medical device manufacturing corporations and published them in the Federal Register. These fees will be effective from October 1 this year until September 30, 2026.
Looking at the rate of increase by item, the review fee for generic drug approvals is the highest at 11.3% higher than the previous year. New drugs (prescription drugs) are up 8.6%, and medical devices are up 7.1%.
On the other hand, the FDA reduced the review fee for biosimilars by 18.4% from the previous year. As the number of review applications increases, the FDA has distributed the overall budget among more corporations, resulting in the fee reduction effect. The number of official meeting programs between FDA reviewers and development companies for biosimilar development (Biological product development·BPD) is projected to increase from 120 this year to 150 next year.
The FDA sets the review fees (user fees) charged to user corporations each year, taking into account inflation, the number of review applications, manufacturing facilities, and the costs of hiring and retaining reviewers.
The number of applications related to prescription drugs expected to be submitted to the FDA next year is estimated to be 2,971, of which 156 are expected to receive fee exemptions. If a developing new drug is designated as an orphan drug, it can receive a fee exemption. Additionally, small corporations with fewer than 500 employees registered in the U.S. are also eligible for fee exemptions for their first application.