Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Biosimilar Pathway Not Smooth For Some Early Applicants

Executive Summary

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

You may also be interested in...



Hurricane Sandy Rains On User Fee Dates, Advisory Committees

FDA will extend user fee goal dates as needed to account for the loss of two days in review cycles resulting from the government office shutdown. The extreme weather conditions led to cancellation of three advisory committees during the week of Oct. 29.

Biosimilar Podium Promotion: FDA Emphasizes Advantages Of Abbreviated Pathway

Biosimilar products are not intended to be stand-alone development programs, agency stresses, noting that early analytical data can allow for more targeted clinical trials later.

Biosimilar User Fee Meeting Schedule Allows FDA Data “Pre-Review”

Agency officials are willing to meet with sponsors during their development programs to look at data and provide advice in part to ensure they remain on track, but also to promote a high first-cycle approval rate.

Related Content

Topics

UsernamePublicRestriction

Register

PS054823

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