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


Tentative-Style Approvals Coming For US Biosimilars?

Executive Summary

A three-judge panel from the US Court of Appeals for the Federal Circuit on July 5 ruled that the 180-day notice of commercial marketing applies to all biosimilar applicants, giving a win to Amgen over Apotex. But in its latest interpretation of the US biosimilars law, the court appears to suggest the FDA needs to establish a tentative-style approval approach for those products, similar to what's employed for generic drugs.


Related Content

Innovators Employ Labyrinthine Defenses To Fend Off Biosimilars
Sandoz's Biosimilar Rejection Ups Risks, But Won't Kill Market
Enbrel Biosimilar Market In Sandoz's Grasp; Will Cost, Litigation Derail It?
Chances Upped Supreme Court Hears Amgen/Sandoz Biosimilars Suit
Court Probes Rationale Of Biosimilars' 180-Day Notice
US Capitol Capsule: Stage Set For More Federal Circuit Biosimilars Interpretive Dancing
Amgen Wins Injunction To Block Apotex Biosimilar
US Capitol Capsule: Fights Over Interpretation Of Biosimilars Law: Disruption To Market's Future?
Court rules biosimilar 'patent dance' optional, but delays Zarxio


Related Companies

Related Deals

What to read next




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