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

Where Are The Biosimilars?

This article was originally published in RPM Report

Executive Summary

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.

You may also be interested in...



Words Of Wisdom For Biosimilar Developers

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.

Biosimilars: Is The Game About To Change In Europe?

Seven years since the first biosimilar hit the European market, these almost-copies have clearly disappointed. Now, though, momentum is building. Attitudes and regulations are slowly changing as cost-pressures continue – with implications for the U.S. And they’re doing so just as regulators review biosimilar Remicade, the first of a potentially far more lucrative set of copycat biologics.

Much “Ado” About Biosimilars

The approval of Kadcyla gives Roche/Genentech yet another new breakthrough cancer therapy in the US. It also offers some clues about the future of biosimilars at FDA.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS081054

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