Scrip 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
UsernamePublicRestriction

How To Label A Biosimilar? Copy The Reference Product, FDA Told Sandoz

Executive Summary

But agency had to weigh how presentation differences between Sandoz’s Zarxio and Amgen’s Neupogen, as well as Neupogen-specific safety information, should be reflected in the biosimilar’s labeling.

You may also be interested in...



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.

FDA Biosimilar Policy Continues To Evolve With Approval Of Sandoz Erelzi

Third biosimilar approved in US brings another iteration of FDA thinking on labeling and naming; etanercept-szzs, which references Amgen's Enbrel, suggests agency might be backtracking on its suffix policy.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS056935

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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