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

BIO Generic Biologics Position: All Products Need "Rigorous" Clinical Trials

Executive Summary

The Biotechnology Industry Organization position statement on generic biologics is firmly against any shortcuts to market for follow-on products.

You may also be interested in...



Generic Biologics: Xigris Approval Suggests Precedent For FDA, GPhA Says

FDA's analysis of manufacturing process changes for Xigris is the latest indication that some form of a generic biologics approval process is feasible, the Generic Pharmaceutical Association says

Generic Biologics: Xigris Approval Suggests Precedent For FDA, GPhA Says

FDA's analysis of manufacturing process changes for Xigris is the latest indication that some form of a generic biologics approval process is feasible, the Generic Pharmaceutical Association says

J&J Eprex EU Label Changed; FDA Investigating Manufacturing Fraud

Johnson & Johnson is recommending intravenous administration of Eprex (epoetin alfa) over subcutaneous administration in chronic renal failure patients in order to decrease the incidence of pure red blood cell aplasia in a July 17 "Dear Doctor" letter to physicians in the EU

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS038283

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