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 Podium Promotion: FDA Emphasizes Advantages Of Abbreviated Pathway

Executive Summary

Biosimilar products are not intended to be stand-alone development programs, agency stresses, noting that early analytical data can allow for more targeted clinical trials later.

You may also be interested in...



Biosimilar Advisory Committees Will Focus Less On Clinical Data

FDA wants panels to look more closely at analytics in lesson learned from Zarxio meeting.

Biosimilar Sponsors Offer Advisory Committee Primer

Extrapolation, uncertainty could prove important when the Oncologic Drugs Advisory Committee considers Sandoz’s filgrastim biosimilar on Jan. 7.

Sandoz Neupogen Biosimilar Heads To ODAC; Cmte. May Be Students As Much As Advisors

January meeting date suggests FDA’s review of Sandoz’s abridged filgrastim application is on track, but Oncologic Drugs Advisory Committee could be challenged by differences between biosimilar and conventional BLA development.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS054804

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