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

Words Of Wisdom For Biosimilar Developers

This article was originally published in RPM Report

Executive Summary

FDA has learned a lot from its biosimilar meetings and sponsor discussions so far – including the areas sponsors struggle with and how others might improve their understanding going forward.

You may also be interested in...



Biosimilar Policy Update: Extrapolation Looks Like Default Approach

As FDA nears the first review deadlines for biosimilar applications, some policy points are coming into sharper focus. Clinical studies for immunogenicity sound like a benchmark requirement, while extrapolation of indications also seems like the agency’s default position.

BIO Responds On Naming

The Biotechnology Industry Organization submitted the following letter in response to this article, after it was published on-line in July.

Where Are The Biosimilars?

An abbreviated pathway for follow-on biologics was one of the biggest issues for biotech investors in the legislative debate over health care reform. Two years after enactment, FDA is still waiting for the first application.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS079638

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