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

Inflectra Analytical Data Eased FDA's 'Residual Uncertainty' About Remicade Differences

Executive Summary

Pink Sheet's Drug Review Profile reveals FDA's second biosimilar got hung up on product quality concerns that suggested potential differences between Celltrion's CT-P13 and its reference biologic, Janssen's infliximab.

Advertisement

Related Content

Biosimilars Statistical Guidance Reflects Early Development Approach
Drug Review Profiles: Behind The Scenes At US FDA
Mapping US FDA's Biosimilar Pathway With Pink Sheet Drug Review Profiles
Evolving Biosimilar Pathway Brings Mid-Review Policy Issues
Biosimilar Naming: FDA Asked Celltrion For Two Kinds Of Suffixes
With Inflectra, FDA Showed Flexibility On Biosimilar Pediatric Study Plans
Inflectra Clinical Development Timeline
Biosimilar Template Revisited: Inflectra Approval Binds And Separates From Remicade
Inflectra's Label Won't Depend On Continuing Study In IBD
Celltrion's Biosimilar Gets FDA Panel Nod Despite Extrapolation Concerns

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS118737

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