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

Federal Circuit dances with biosimilar law's complexity in Zarxio fight

This article was originally published in Scrip

Executive Summary

While the case before the US Court of Appeals for the Federal Circuit on 3 June was a dispute between Amgen and Novartis' Sandoz unit over how soon the latter firm should be able to market its biosimilar medicine Zarxio (filgrastim-sndz), it was the knotty intricacies of the Biologics Price Competition and Innovation Act (BPCIA) – the law that created the regulatory pathway for the FDA to approve biosimilars – that was on trial.

Advertisement

Related Companies

Advertisement
UsernamePublicRestriction

Register

SC028898

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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