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 Advisory Committee Reviews: Necessity Or Nuisance?

Executive Summary

FDA panelists' confusion over biosimilarity and overwhelming approval endorsements following glowing agency reviews suggest the meetings may not be having much impact on FDA deliberations; however, agency sees an opportunity to learn from what its external experts don't understand about biosimilars.

Advertisement

Related Content

Hospira's Epogen Biosimilar Appears Poised For Quick Advisory Cmte. OK
Biosimilars Still Flummoxed By Neulasta: Sponsors Now 0 For 2 At FDA
Inflectra Analytical Data Eased FDA's 'Residual Uncertainty' About Remicade Differences
Biosimilar Non-Medical Switching: Advocacy Groups, FDA Advisors Push For Action
Biosimilar Advisory Committee Features Actual Debate About Biosimilarity
Amgen's Humira Biosimilar Gains Nod From Panel Perplexed By Regulatory Pathway
Biosimilars: Does FDA Caution Make Advisory Committee A Rubber Stamp?
FDA Met Biosimilar Review Timelines But Missed Meeting Goals In 2015
Pending Biosimilars
Biosimilar Advisory Committees Will Focus Less On Clinical Data

Topics

Related Companies

Related Deals

Advertisement
UsernamePublicRestriction

Register

PS118797

Ask The Analyst

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

All set! This Question has been sent to 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