Pink Sheet 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

Zarxio Clinical Development Timeline

Executive Summary

Chronicle of the development and review of Sandoz’s filgrastim-sndz, a biosimilar to Amgen’s Neupogen.

You may also be interested in...



Behind The Approval Letter: Drug Review Profiles

A listing of the Drug Review Profile series articles published in the Pink Sheet.

As Biosimilar Meeting Requests Rise, So Do FDA's Performance Goal Challenges

Growing number of products participating in BsUFA program, coupled with budgetary challenges, have made FDA attainment of some early goals under the Biosimilar User Fee Act difficult.

Zarxio Syringe’s Limitations May Delay Decision On Neupogen Interchangeability

FDA review documents for Sandoz’s filgrastim-sndz suggest that biosimilar sponsors need to consider how differences in delivery device from the reference product will play out under the 351(k) pathway, including whether new device designs and human factors data will be needed to secure interchangeability.

Related Content

Topics

UsernamePublicRestriction

Register

SC143367

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

Cancel