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

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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

You may also be interested in...



Apotex Biosimilar Goes To FDA, But May Enter Crowded Market

Pegfilgrastim product, a collaboration with the Indian firm Intas, may have to compete with multiple filgrastim products, along with its reference biologic, Amgen’s Neulasta.

Sandoz’s Biosimilar Filing Is Culmination Of Paradigm Shift In FDA Drug Review

FDA clinical reviewers moved from traditional “new drug” review mode to determining the evidence needed to demonstrate a follow-on product is highly similar to the reference biologic, Sandoz exec says, describing firm’s interactions with FDA on its filgrastim 351(k) application.

Biosimilar Podium Promotion: FDA Emphasizes Advantages Of Abbreviated Pathway

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS076796

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