Subscribe
pills-istock-525984851
sprng23 / iStockphoto.com
12 June 2017Americas

SCOTUS allows early notice from biosimilar applicants

The US Supreme Court has ruled that biosimilar applicants may provide notice to the manufacturer before obtaining a licence from the Food and Drug Administration (FDA) for their biosimilars.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk


More on this story

Americas
Fed Circuit erred in Sandoz v Amgen, says solicitor general
28 February 2017   The US Court of Appeals for the Federal Circuit erred in holding that biosimilar applicants must give 180 days’ pre-marketing notice after an application has been approved by the US Food and Drug Administration, according to the acting solicitor general.
Americas
BIO 2017: Panellists talk Amgen Sandoz biosimilar battle
23 June 2017   Earlier this month, the US Supreme Court handed down its decision in the biosimilars battle between Amgen and Sandoz, centring on the Biologics Price Competition and Innovation Act.
Americas
State law can’t compel ‘patent dance’, rules Federal Circuit
15 December 2017   State law cannot force drug makers to participate in the ‘patent dance’ provided for by the Biologics Price Competition and Innovation Act.


Editor's picks

Americas
UPC bans Meril Life Sciences from selling infringing heart valve
19 November 2024

Editor's picks

Americas
UPC bans Meril Life Sciences from selling infringing heart valve
19 November 2024
Americas
Big Pharma counsel embrace AI but data and legal risks loom
24 October 2024
Asia
President Xi sends message to AIPPI’s World Congress
22 October 2024
Unified Patent Court
‘Every CMS filing is painful’: Notes from a Unified Patent Court dispute
26 September 2024
Unified Patent Court
Interview: Klaus Grabinski, UPC Court of Appeal president
24 September 2024
Unified Patent Court
‘Be prepared, and don’t assume at the UPC’: Christopher Stothers
12 September 2024

More on this story

Americas
Fed Circuit erred in Sandoz v Amgen, says solicitor general
28 February 2017   The US Court of Appeals for the Federal Circuit erred in holding that biosimilar applicants must give 180 days’ pre-marketing notice after an application has been approved by the US Food and Drug Administration, according to the acting solicitor general.
Americas
BIO 2017: Panellists talk Amgen Sandoz biosimilar battle
23 June 2017   Earlier this month, the US Supreme Court handed down its decision in the biosimilars battle between Amgen and Sandoz, centring on the Biologics Price Competition and Innovation Act.
Americas
State law can’t compel ‘patent dance’, rules Federal Circuit
15 December 2017   State law cannot force drug makers to participate in the ‘patent dance’ provided for by the Biologics Price Competition and Innovation Act.

More on this story

Americas
Fed Circuit erred in Sandoz v Amgen, says solicitor general
28 February 2017   The US Court of Appeals for the Federal Circuit erred in holding that biosimilar applicants must give 180 days’ pre-marketing notice after an application has been approved by the US Food and Drug Administration, according to the acting solicitor general.
Americas
BIO 2017: Panellists talk Amgen Sandoz biosimilar battle
23 June 2017   Earlier this month, the US Supreme Court handed down its decision in the biosimilars battle between Amgen and Sandoz, centring on the Biologics Price Competition and Innovation Act.
Americas
State law can’t compel ‘patent dance’, rules Federal Circuit
15 December 2017   State law cannot force drug makers to participate in the ‘patent dance’ provided for by the Biologics Price Competition and Innovation Act.

More features

Bayer gains exclusive licence for heart drug in Japan
EPO delivers key Novo Nordisk, GSK and Inhibrx rulings
McGuireWoods expands team with ex-Novo Nordisk GC
Paul, Weiss swoops for senior duo from Weil, Gotshal
UPC bans Meril Life Sciences from selling infringing heart valve
SCOTUS denies Alvogen unit's appeal to sell Bausch Xifaxan generic
Kathi Vidal to rejoin previous firm as partner following USPTO departure
GSK triumphs in EPO appeal, revoking Pfizer patent