Pink Sheet is part of the Business Intelligence Division 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

Will FDA Answer The Big Biosimilars Questions?

This article was originally published in SRA

Executive Summary

AbbVie is hoping that US lawmakers will get to the bottom of why the Food and Drug Administration did not require Sandoz to identify in the labeling of Zarxio (filgrastim-sndz) that the product is a biosimilar or clearly state the drug had not been found to be interchangeable – something regulators had earlier said in a draft guidance was "necessary" to declare.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

All set! This Question has been sent to 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

Add a personalized Question to your Analyst