Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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: FDA, EMA Developing Common Data Package Guidance

This article was originally published in The Pink Sheet Daily

Executive Summary

Guidance is “emerging” that will allow sponsors to use data from products not licensed in their respective regions in applications.

You may also be interested in...



Biosimilar Draft Guidance Outlines Three-Arm Bridging Studies For Non-U.S. Products

Clinical pharmacology data could help biosimilar sponsors pursue a more global development plan.

Biosimilar Draft Guidance Outlines Three-Arm Bridging Studies For Non-U.S. Products

Clinical pharmacology data could help biosimilar sponsors pursue a more global development plan.

FDA Oversight By House To Focus On User Fees, Compounding Law

Among the Energy and Commerce Committee’s priorities are ensuring correct implementation of the generic drug and biosimilar user fee programs, whose launches have experienced some hiccups.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS077124

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