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

Inflectra Label Not Exactly Silent On Remicade's Orphan-Protected Claim

This article was originally published in The Pink Sheet Daily

Executive Summary

Although FDA did not approve the biosimilar for pediatric ulcerative colitis, Inflectra labeling states that a pediatric assessment demonstrates it is 'safe and effective in another pediatric indication.'


Related Content

Biosimilars: Postmarketing Data Alone Not Enough For Interchangeability
Amgen's Amjevita Approved As First Biosimilar To AbbVie's Humira
Evolving Biosimilar Pathway Brings Mid-Review Policy Issues


Related Companies