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

Biosimilars: What Will The Second Advisory Committee Tell Us?

This article was originally published in The Pink Sheet Daily

Executive Summary

Celltrion will have the most at stake next week, but future sponsors – and FDA itself – could learn a lot about how reviews of these new products work.

You may also be interested in...



FDA Sets New Goal For Biosimilar, Drug Promotion Guidances

Agency plans to issue 102 new and revised draft guidances this year, including those on use of multiple endpoints in clinical trials, 180-day exclusivity, and ANDA refuse-to-receive standards.

Zarxio Syringe’s Limitations May Delay Decision On Neupogen Interchangeability

FDA review documents for Sandoz’s filgrastim-sndz suggest that biosimilar sponsors need to consider how differences in delivery device from the reference product will play out under the 351(k) pathway, including whether new device designs and human factors data will be needed to secure interchangeability.

Gene Therapy: Pediatric Development Could Start Sooner Than Sponsors Think – FDA OTP Director

Nicole Verdun said children could participate in gene therapy clinical trials earlier if the necessary controls are in place.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS079168

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