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

US FDA Biosimilar Guidance Update Will Relax Interchangeability Standards

Executive Summary

Updated interchangeability guidance is one of several 'incremental reforms' agency is working on that could ease development burden for biosimilars, Commissioner Scott Gottlieb says.

You may also be interested in...



Interchangeability Won’t Solve US Biosimilar Market’s Woes, FDA’s Gottlieb Says

FDA's Biosimilar Action Plan aims to boost approvals, but Commissioner Gottlieb says he's had a change of heart about how much impact an interchangeability designation can have on market uptake.

Interchangeability Won’t Solve US Biosimilar Market’s Woes, FDA’s Gottlieb Says

FDA's Biosimilar Action Plan aims to boost approvals, but Commissioner Gottlieb says he's had a change of heart about how much impact an interchangeability designation can have on market uptake.

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

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

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS122952

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