Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Ringside For Zarxio At Supreme Court: Biosimilar Stakeholders Line Up

Executive Summary

High court set to determine timing of biosimilar marketing and how parties handle patent disputes in Sandoz v. Amgen. Stakeholders say the outcome will impact innovation, access to biosimilars and future litigation.

You may also be interested in...



A Look At Payers' Early Game Plans For Driving Biosimilar Use

Interviews with US payers suggest that at first they are more likely to focus on promoting biosimilars in treatment-naïve patients, as opposed to switching those on branded drugs, according to a new Datamonitor report.

Biosimilar Litigation: Genentech Avastin Suit Tossed; Janssen Remicade Case Uncertain

US court dismisses Genentech suit over Amgen's patent dance moves; Janssen v. Celltrion trial is postponed as parties fight over Janssen's standing to sue; and Amgen wants to bar AbbVie citizen petition filers from seeing its Amjevita information.

Biosimilar sponsors can avoid 'patent dance' in US, but innovators win extra exclusivity

Biosimilar sponsors won a partial victory in the battle over the meaning of the US biosimilars statute as an appeals court found that the patent exchange process laid out in the law is optional1. But avoiding the disclosure and negotiation procedures or 'patent dance' in the Biologics Price Competition and Innovation Act opens them up to litigation over a larger number of patents, which could be problematic for biosimilars of newer biologics.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

GB002027

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