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

Two Months To Add Two Words – Biosimilar Supplement Review Times May Be Hindering Uptake

Executive Summary

Biosimilar supplement approvals by the US FDA take on average about five months as sponsors request easier and quicker ways to update labels.

You may also be interested in...



US FDA’s Biosimilars Group Will Conduct Some Supplement Reviews, Become ‘Like Another Discipline’

Office of Therapeutic Biologics and Biosimilars Director Sarah Yim says in an interview with the Pink Sheet that more staff are being added to deal with labeling supplements.

US FDA’s Biosimilars Group Will Conduct Some Supplement Reviews, Become ‘Like Another Discipline’

Office of Therapeutic Biologics and Biosimilars Director Sarah Yim says in an interview with the Pink Sheet that more staff are being added to deal with labeling supplements.

FDA Publishes BsUFA III Commitment Letter Ahead Of 2022 Renewal

Following months of negotiations with industry and stakeholders, the FDA has released the commitment letter for the third iteration of its five-year Biosimilar User Fee Amendments program, marking another step ahead of its reauthorization.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS125170

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