Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Biosimilar User Fee Revenue Missed Estimates Again In FY 2019, Spending Reduced

Executive Summary

US FDA said that total BsUFA obligations also decreased compared to estimates, but maintains optimism about future revenue increases.

You may also be interested in...



FDA Rebates Biosimilar Fees And Limits Generic Fee Hike

The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.

US FDA Rebates Biosimilar Fees, Limits Generic Fee Hike In FY 2022

The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.

BsUFA III Negotiations Nearly Done; Commitment Letter Being Written

Supplement approval timeline and regulatory science issues apparently have been resolved.

Related Content

Topics

UsernamePublicRestriction

Register

PS142423

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel