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

FDA “Busy” With Biosimilars; Sponsors Already In Pre-IND Meetings

Executive Summary

Several sponsors appear to be taking advantage of the FDA’s biosimilar pathway, even though the agency has yet to clarify how it will handle the applications.

You may also be interested in...



Biosimilar Pathway Not Smooth For Some Early Applicants

FDA says some candidates have appeared so different from their reference products that sponsors were told the molecule could not be a biosimilar.

FDA Meetings With Biosimilar Sponsors Aim To Make 351(k) Pathway OK

Short public meeting on the biosimilar user fee agreement suggests the proof will be in the scheduling.

Biosimilar Players Will Be Manufacturers Large And Small, Analyst Predicts

The biosimilar manufacturing and development process has been optimized to ensure multiple companies can enter the market, Sanford C. Bernstein & Co. Senior Health Care Analyst Ronny Gal argues, but uncertainty will remain until FDA designs its approval system.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS053397

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