Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Signals Interest In Requiring Unique Biosimilar Names

This article was originally published in The Pink Sheet Daily

Executive Summary

OND Director Jenkins expresses concern at a public hearing that the agency could miss or confuse some spontaneous adverse events if biosimilars are not distinguished from their reference product.

You may also be interested in...



Supply Chain Security Issues To Emerge During Subcommittee Hearing On PDUFA

FDA's Biosimilar Strategy Will Rely On "Fingerprint" Technology To Limit Trials

European experiences with "totality of the evidence" method also seem to be shaping policy, according to FDA article in NEJM.

FDA's Biosimilar Strategy Will Rely On "Fingerprint" Technology To Limit Trials

European experiences with "totality of the evidence" method also seem to be shaping policy, according to FDA article in NEJM.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS071476

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