Scrip 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

UsernamePublicRestriction
UsernamePublicRestriction

The Big Biosimilars Questions: Will Senate Get Answers?

This article was originally published in Scrip

Executive Summary

When a Senate subcommittee of the Health, Education, Labor and Pensions (HELP) panel calls Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, to testify on Sept. 17, AbbVie is hoping lawmakers will get to the bottom of why the agency did not require Novartis and its Sandoz unit to identify in the labeling of Zarxio (filgrastim-sndz) the product is a biosimilar and did not clearly state the drug had not been found to be interchangeable – something regulators had earlier said in a draft guidance was "necessary" to declare.

Advertisement

Related Companies

Related Deals

Advertisement
UsernamePublicRestriction

Register

SC029756

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Ask your question to our analysts

Cancel