Pink Sheet is part of the Business Intelligence Division 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
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.
Advertisement

Related Content

Biosimilars: After FDA's Public Meeting, Is A Payer Summit Needed Too?
Biosimilars: After FDA's Public Meeting, Is A Payer Summit Needed Too?
Biosimilars: After FDA's Public Meeting, Is A Payer Summit Needed Too?
Waxman Says Biosimilar Pathway Will Push Applicants To BLA
Waxman Says Biosimilar Pathway Will Push Applicants To BLA
Sanders Bill Would Allow Biosimilar “Pay-For-Data” System
FDA Searches For Clinical Trial Middle Ground At Biosimilar Hearing

Topics

Advertisement
UsernamePublicRestriction

Register

PS052949

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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