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


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to show no clinically meaningful differences with the reference product could confuse prescribers, agency says in new draft guidance.


Related Content

Biosimilar Labeling: US FDA’s Final Guidance Means Status Quo For Sponsors
Biosimilar User Fee Agreement Puts FDA On Hook For Delayed Guidances
FDA To Update Quality Metrics Guidance
Biosimilar Labeling: Should FDA Just Throw Up Its Hands And Finalize Guidance?
Evolving Biosimilar Pathway Brings Mid-Review Policy Issues
FDA Sets New Goal For Biosimilar, Drug Promotion Guidances
Biosimilar Labeling Needs Greater Transparency, BIO And PhRMA Say


Related Companies




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