Pink Sheet is part 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

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...



Can Biosimilar Studies Be Conducted Solely In Healthy Volunteers?

Coherus refutes Apotex argument that Neulasta biosimilars must be studied in at least one patient population. Its application could face delay as no advisory committee meeting has been scheduled ahead of its June 9 user fee date.

Can Biosimilar Studies Be Conducted Solely In Healthy Volunteers?

Coherus refutes Apotex argument that Neulasta biosimilars must be studied in at least one patient population. Its application could face delay as no advisory committee meeting has been scheduled ahead of its June 9 user fee date.

Biosimilar Tentative Approvals Could Flow From US Supreme Court Case

If high court decides that biosimilar sponsors must wait until licensure before providing 180-day notice of commercial launch, FDA may face pressure to start granting tentative licenses for 351(k) applications, industry lawyer says.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS142970

Ask The Analyst

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

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