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

Biosimilars’ Next Big Hurdle For FDA Could Be Clinician Education

Executive Summary

Companies and other groups want clear FDA communication on biosimilars as pharmacists look for an Orange Book-like reference manual to be ready for prescriptions.

You may also be interested in...



FDA Sets Biosimilar Application Fees, But Is Silent On Volume Projections

A Federal Register notice outlines the new user fee amounts and suggests that President Obama’s budget projections anticipated as many as 10 marketing applications, but the mix of INDs and full applications is unknown.

FDA’s TV Ad Review Is Unconstitutional, PhRMA Says, Or Maybe Should Be A Reg

A draft guidance that outlines six categories of drug ads FDA wants submitted for prior review is a violation of advertisers’ free speech rights, the industry group argues. Other comments float a storyboard compromise.

Biosimilar Suffix Naming Idea Trips On Dispensing Problem

American Pharmacists Association tells FDA during biosimilar guidance hearing that using suffixes to create unique names will be problematic. FDA may be leaning toward the unique names, saying published literature indicates adequate safety tracking is not possible without them.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS054485

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