Pink Sheet 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

US Supreme Court Permits Earlier Biosimilar Launches; Penalty For Declining Patent Dance Uncertain

Executive Summary

Court says biosimilar sponsors may provide 180-day notice of marketing prior to FDA approval; Federal Circuit to decide if innovators can seek an injunction under state law if sponsors do not provide application and manufacturing information; Justice Breyer offers FDA invitation to weigh in.

You may also be interested in...



Is CREATES Act Equipped To Handle Biosimilar Complaints?

Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.

Is CREATES Act Equipped To Handle Biosimilar Complaints?

Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.

CREATES Act Approaches Finish Line But Legislation May Fail To Launch

Broad bipartisan support and billions in projected savings mean that bill may finally pass. But whether it will work as intended to improve generic access to market remains as questionable as ever.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS120853

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