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

Waiting For Biosimilars: From Manufacturing To Litigation, Stakeholders Prepare For U.S. Market

Executive Summary

Leading players in the biosimilars realm discuss possible roadblocks to development, the battle over naming and substitution, and strategies to avoid the patent litigation dance.

You may also be interested in...



Celltrion’s Remicade Biosimilar Takes U.S. Regulatory Shortcuts

After just one year of working with the U.S FDA, the South Korean company is positioning itself to launch its first monoclonal antibody biosimilar in the U.S. market.

GPhA And Actavis Divorcing: Biosimilars Behind The Rift

Actavis, the hybridizing generics giant that once helped keep GPhA together, now appears to be splitting off in a dispute over state substitution strategy.

FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics

The agency’s first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS056191

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