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

Biosimilar Application Pathway Likely To Travel Through Courts

Executive Summary

The courts likely will get involved in biosimilars even if FDA decides which application pathway a biosimilar would travel, a consultant and former FDA official said.

You may also be interested in...



Biosimilars: After FDA's Public Meeting, Is A Payer Summit Needed Too?

FDA may be forced to campaign for support of its biosimilar decisions in the health care community to ensure entities like hospital Pharmacy and Therapeutics Committees embrace the products.

Biosimilars: After FDA's Public Meeting, Is A Payer Summit Needed Too?

FDA may be forced to campaign for support of its biosimilar decisions in the health care community to ensure entities like hospital Pharmacy and Therapeutics Committees embrace the products.

Waxman Says Biosimilar Pathway Will Push Applicants To BLA

The outgoing chairman of the House Energy and Commerce Committee said the new abbreviated biosimilar pathway FDA is now formulating likely will not attract many applicants.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS052949

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