Pink Sheet is part 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

With Inflectra, FDA Showed Flexibility On Biosimilar Pediatric Study Plans

Executive Summary

Drug Review Profile: Agency reviewed Celltrion's application while also negotiating an initial Pediatric Study Plan, and it crafted an exemption so that Inflectra and other biosimilars will not need to be studied in Crohn's disease patients as young as two years old.

You may also be interested in...



Drug Review Profiles: Behind The Scenes At US FDA

A year in our long-running series of deep dives into FDA review documents.

Mapping US FDA's Biosimilar Pathway With Pink Sheet Drug Review Profiles

First four 351(k) BLA approvals highlight emerging FDA positions on issues from naming to the role of biosimilar-specific data, as detailed in Pink Sheet's Drug Review Profile series.

Mapping US FDA's Biosimilar Pathway With Pink Sheet Drug Review Profiles

First four 351(k) BLA approvals highlight emerging FDA positions on issues from naming to the role of biosimilar-specific data, as detailed in Pink Sheet's Drug Review Profile series.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS118738

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