Sandoz Takes Enbrel Fight To The US Supreme Court

Federal Circuit Decisions Last Year Leave Potential Eight-Year Wait On Etanercept

Sandoz had hinted that further legal action was viable as it looks to introduce biosimilar competition to Amgen’s Enbrel blockbuster in the US. The Novartis subsidiary has now taken its fight to the very highest court.

US-Supreme-Court_V1_1200
Sandoz is seeking US Supreme Court Review of the Fed. Cir.'s 1 July 2020 decision. • Source: Shutterstock

Sandoz is taking one last shot to topple US patents blocking a path for its biosimilar to Amgen’s Enbrel (etanercept), filing a petition with the US Supreme Court for certiorari review of an unfavorable US Court of Appeals for the Federal Circuit decision which upheld the validity of two patents shielding the $5bn autoimmune diseases treatment.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Biosimilars

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By 

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

Amgen’s Aflibercept Starts Strong As Regeneron Counts Cost Of Eylea Competition

 
• By 

Amgen told investors during its 1 May first-quarter earnings call that its Pavblu biosimilar to Eylea 2mg had flown out of the gates, while Regeneron admitted “some difficult news related to our retinal franchise.”

BGMA Becomes Medicines UK

 
• By 

The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By 

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

More from Products

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By 

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
• By 

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

What’s Next? Five Things To Look Out For In May

 
• By 

Generics Bulletin previews the most noteworthy and anticipated events for May 2025.