Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

House Appropriators Tip-Toe Into Biologics Transition Controversy

Executive Summary

US FDA instructed to use the "Program" when assessing insulin applications with review goals before the 2020 transition date, but appropriations report does not explicitly urge elimination of the application "dead zone."

You may also be interested in...



Senate Wants Priority Review For 'Deemed' Biologics Not Approved By Deadline

Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.

Mylan/Biocon’s Insulin Glargine Has Narrow Window For Approval In US

Thirty-month stay resulting from Sanofi’s patent lawsuit expires on 18 March 2020, two days before Mylan’s application must receive final approval to avoid getting caught in the transition of insulins from drug to biologic regulation. Pre-approval inspection of Biocon’s manufacturing facility resulted in 12 ‘largely procedural’ observations, company says.

Biologics Transition 'Dead Zone' Could Be Eliminated Under US Senate Bill

Discussion draft includes provision requiring completion of assessments of transitioning NDA applications filed by 23 September, even if review lasts beyond the official 2020 transition date.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS125411

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