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

Biosimilar Labeling: FDA Says Leave Comparability Data Out

This article was originally published in The Pink Sheet Daily

Executive Summary

Data developed to show no clinically meaningful differences with the reference product could confuse prescribers, agency says in new draft guidance.

You may also be interested in...



Biosimilar Labeling: US FDA’s Final Guidance Means Status Quo For Sponsors

Advice document, little changed from a March 2016 draft, continues to reflect agency’s view that clinical studies supporting a demonstration of biosimilarity should not be included in labeling.

Biosimilar Labeling: US FDA’s Final Guidance Means Status Quo For Sponsors

Advice document, little changed from a March 2016 draft, continues to reflect agency’s view that clinical studies supporting a demonstration of biosimilarity should not be included in labeling.

Biosimilar User Fee Agreement Puts FDA On Hook For Delayed Guidances

Draft guidelines on interchangeability and statistical considerations due by end of 2017, suggesting long-awaited documents may not see the light of day this year as many had hoped.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS079272

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