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

Follow-On Biologics' Bumpy Pathway: Was The CBO Savings Score Too High?

Executive Summary

The promise of health care savings from an abundance of biosimilar drugs brought to market under recently passed reforms may go unfulfilled if intellectual property provisions of the law aren't addressed, members of a panel at the BIO annual meeting in Chicago said May 5

You may also be interested in...



CBER Director Midthun Retiring; Legacy Includes Biosimilar Principles, Avastin Withdrawal

While CBER is often perceived to be as much focused on research as it is on application review, Midthun was central to many key policy debates.

FDA Antibiotic Task Force Developing Standards To Help Products GAIN Traction

Task force model emerging as agency’s standard approach to implementing statutory directives to enhance product development.

PDUFA Cost Offset In House Focuses On FDA Petition Review, Not REMS

Faced with a CBO estimate that H.R. 5651 will increase federal spending in fiscal years 2013 through 2022, the House Energy and Commerce Committee applies a section that speeds FDA decisions on some petitions to biosimilars. This contrasts with the Senate bill, which allows FDA to require brand companies to sell products covered by limited distribution systems to generic firms.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS052228

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