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

Concern Over Biosimilar-To-Biosimilar Switch Could Impact Approval, US FDA Official Says

Executive Summary

OTBB Director Sarah Yim tells the Pink Sheet that FDA cannot make an official determination that biosimilar-to-biosimilar switches are acceptable, but the agency does think about how a product will be used in the market while assessing the application.

You may also be interested in...



Study Offers Support For Biosimilar-To-Biosimilar Switching

A new paper has examined the issue of biosimilar-to-biosimilar switching, concluding that it is a safe and effective clinical practice but highlighting a lack of current health authority regulations or guidance on the subject.

How Star Wars Explains Biosimilar Labeling Problems

US FDA largely writes biosimilar labels that are the same as their reference products even though it’s not required, which could hinder product development and uptake, experts say.

US FDA Unlikely To Issue Broad Biosimilar Guidance Saying Comparative Clinical Studies Unnecessary

OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS146948

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