Generics Bulletin 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

US Biosimilar Sponsors Seek Off-The-Record Discussions

Biosimilar Sponsors Want Off-The-Record Labeling Discussions With FDA

Executive Summary

Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions without written record; negotiations for BsUFA III may be opportunity to create such a process.

You may also be interested in...



FDA Guides On Adding Biosimilar Indications

Sponsors may submit supplemental applications for additional indications in advance so that approval will coincide with expiration of a reference product’s exclusivity or patent protection, new draft guidance states; agency targets six-month review of such supplements, rather than the 10 months provided under BsUFA II.

Playing It Safe? Hahn's Biosimilar View

US FDA Commissioner nominee gave a general, scripted answer to a question about biologic patents, but did Stephen Hahn inadvertently go against the agency's stance on the issue?

FDA's Biosimilars Meeting Management Should Improve After Reorg In New Drug Office

US FDA met more biosimilar user fee program meeting performance goals in FY 2018 compared to prior year but still fell short in scheduling for three of five types of meetings. Office of New Drugs reorganization, once completed, should address some logistical scheduling issues.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

GB149442

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