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

Believing In Biosimilars: Industry Takes Long View on FDA Pathway

This article was originally published in RPM Report

Executive Summary

FDA is open for business on biosimilars as it works out the specifics of the new review pathway. But for companies considering an entry into the space, two big questions still remain: Does a profitable market exist, and how conservative will FDA be on those initial approvals? Executives from across the biopharmaceutical industry weigh in during The RPM Report’s FDA/CMS Summit.

You may also be interested in...



Beyond ObamaCare: Big Pharma, Health Reform and the 2012 Elections

Most everyone can agree that health care costs are spiraling out of control. President Obama and his Republican challenger Mitt Romney each say they have a plan to cut spending. But while those are being debated, a high-profile group of former Obama advisers are suggesting something much more radical: a systematic change in the way we pay for health care. Could it be a blueprint for a second Obama term?

Biosimilarity vs. “Cognitive Dissonance”: The Ongoing Challenges to New FDA Pathway

FDA is still awaiting its first biosimilar product application – and there is no reason to expect a flood of products any time soon. The new pathway faces legal, logistical and resource obstacles. But the most important barrier may be the need for a mindset change.

Is Merck Less Bullish on Biosimilars?

Of all the Big Pharma manufacturers, none seemed more optimistic about the commercial potential of biosimilars than Merck. But over the last several months, Merck shut down its BioVentures Group and skipped an FDA public meeting on the abbreviated approval pathway. Has Merck soured on biosimilars?

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS080792

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