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

Biosimilars For US Market May Be Able To Rely On EU-Licensed Reference Products

Executive Summary

Commissioner Scott Gottlieb says move could allow biosimilar sponsors to avoid anti-competitive efforts by brand sponsors in US.

You may also be interested in...



CREATES Act To Face Major Reshaping By Innovator-Friendly Amendments On Senate Floor

The Creating and Restoring Equal Access to Equivalent Samples Act clears US Senate Judiciary Committee.  During markup, Sens. Hatch, R-Utah, and Cornyn, R-Tex., preview future amendments that would benefit innovators.

Generic Company Disclosure Could Be A 'Speedbump' Against Misuse Of US FDA Access Inquiry List

Generic companies might get more transparency than they bargained for if there is misuse of the public list of reference drugs they say they have trouble obtaining; at BIO annual meeting, FDA Commissioner Gottlieb also suggests VA procurement of brand drugs as possible alternative if innovators continue to hinder access for bioequivalence testing.

Shared REMS: US FDA Wants Brisk Brand-Generic Talks, Might Give Unilateral Waivers

New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

GB002469

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