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

Apotex Moves To Block Coherus' Neulasta Biosimilar; Asks FDA To Require Patient Studies

Executive Summary

Apotex argues that biosimilar studies in healthy volunteers are not sufficient to show clinically meaningful differences with the reference product; Coherus says it believes its application is scientifically sound.

You may also be interested in...



Keeping Track: FDA Starts November With A Bang

The latest drug development news and highlights from our FDA Performance Tracker.

Neulasta Biosimilar From Coherus Needs Better Immunogenicity Assay After Stumble At US FDA

Despite facing one-year delay, Coherus is buoyed by FDA’s apparent support for its decision not to conduct clinical study in cancer patients; agency requests company develop more sensitive immunogenicity assay and reanalyze subset of samples from study conducted in healthy subjects.

Neulasta Biosimilar From Coherus Needs Better Immunogenicity Assay After Stumble At US FDA

Despite facing one-year delay, Coherus is buoyed by FDA’s apparent support for its decision not to conduct clinical study in cancer patients; agency requests company develop more sensitive immunogenicity assay and reanalyze subset of samples from study conducted in healthy subjects.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS120533

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