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


Is FDA Reviewing A Biosimilar Marketing Application?

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency changes its rhetoric on the subject, inviting speculation about whether a marketing application has been received.

You may also be interested in...

Biosimilar Guidances Expected In ‘Near Future,’ But Unnecessary, FDA Says

Naming and labeling questions will likely be resolved with agency actions on pending biosimilar applications.

Korea’s Celltrion, Partner Hospira Win Drug Procurement Bid In Norway For Infliximab Biosimilar

Celltrion’s biosimilar infliximab has won over J&J’s Remicade in Norway’s national drug procurement bidding, and will be priced at a 39% discount to the originator product.

As They Look To The U.S., Celltrion And Hospira Win Approval For Remicade Biosimilars In Canada

The first biosimilar MAb approval in Canada could mean Korea’s Celltrion and its partner Hospira are getting closer to filing in the U.S.

Related Content


Related Companies

Latest Headlines
See All



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