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

High Barriers To Entry For Biogenerics Will Lead To Lower Cost Savings – Duke

Executive Summary

Challenges facing potential manufacturers of follow-on biologics such as a higher cost of entry and initially slower uptake will result in lower cost savings than those seen with the launch of small molecule generics, according to Duke University economist Henry Grabowski

You may also be interested in...



505(b)(2) Resurrection, FDA Guidance To Bless Follow-On Biologics Pathway

FDA's decision to develop guidance for development of follow-on versions of biologics approved under the Food, Drug & Cosmetic Act indicates the agency has accepted section 505(b)(2) of the FD&C Act as a viable pathway for approval of such products

Generic Biologics Bill’s Key Battleground May Be Senate Health Committee

Legislation to create a pathway for FDA approval of generic biologics should be attached to the reauthorization of the Prescription Drug User Fee Act, Sen. Charles Schumer, D-N.Y., said at a Feb. 14 press conference announcing reintroduction of the bill

Follow-On Biologics Could Save Medicare $14 Bil. Over 10 Years – PCMA

Creating a way for FDA to approve follow-on biologics could lead to savings of more than $14 billion for Medicare Part B from fiscal 2007 to 2016, according to a "preliminary assessment" that the Pharmaceutical Care Management Association released Jan. 4

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS048226

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