Guidance Explains User Fee Structure for Biosimilars

Article

The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.

FDA published final guidance on Jan. 23, 2020 that provides information regarding FDA’s implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the FDA Reauthorization Act of 2017. The guidance details the new fee structure and types of fees created as a result of BsUFA II.

Specifically, the guidance explains the process for submitting payments, the consequences for not paying BsUFA fees, and how to request reconsideration of a user fee assessment. FDA also describes how it determines which products are subject to fees. It does not, however, address how the agency determines and adjusts fees each fiscal year or how it addresses implementation of other user fee programs.

Source: FDA

 

Recent Videos
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Kate Coleman, vice president regulatory affairs, quality and compliance, Arriello, chats about industry trends and technological advances.
Industry Outlook 2025: The Rising Prominence of AI in Pharma
Adam Sherlock, CEO of Qinecsa, discusses the changing political landscapes in the US and Europe and how that may affect the bio/pharma industry.
© 2025 MJH Life Sciences

All rights reserved.