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

Evolving Biosimilar Pathway Brings Mid-Review Policy Issues

Executive Summary

Drug Review Profile: Labeling, unique fee structure among many challenges that Inflectra sponsor Celltrion and FDA had to navigate in nascent regulatory pathway.

Advertisement

Related Content

Inflectra Analytical Data Eased FDA's 'Residual Uncertainty' About Remicade Differences
Biosimilar Naming: FDA Asked Celltrion For Two Kinds Of Suffixes
With Inflectra, FDA Showed Flexibility On Biosimilar Pediatric Study Plans
Inflectra Clinical Development Timeline
Inflectra Reviewers
Biosimilar Launch Notification Delay Remains In The US, Might Not Matter For Newer Products
Pfizer's Remicade Biosimilar: Sept. 15 Is Earliest Launch Date
Biosimilar Template Revisited: Inflectra Approval Binds And Separates From Remicade
Inflectra Label Not Exactly Silent On Remicade's Orphan-Protected Claim
Biosimilar Labeling: FDA Says Leave Comparability Data Out

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS118739

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Add a personalized Question to your Analyst

Cancel