1. Generics Bulletin

Nine More Years? Sandoz Loses Again On Enbrel Biosimilar

Sandoz Has Held FDA Approval For Its Erelzi Version Since 2016

 
• By Dean Rudge

Sandoz has failed to overturn on appeal an invalidity ruling for two patents covering Enbrel in the US, barring a path to market for its Erelzi biosimilar, potentially until patent expiry in 2029.

2029_Ice
Sandoz' biosimilar etanercept launch plans may be on ice until 2029 • Source: Shutterstock

Biosimilar competition in the US to Amgen’s Enbrel (etanercept), the $5bn autoimmune diseases treatment, is at risk of not materializing for nine more years after a US Court of Appeals upheld the validity of two patents covering the drug, at the expense of etanercept biosimilar sponsor Sandoz.

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More from Legal & IP

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

 
• By Dave Wallace

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 Dean Rudge

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.

Glenmark’s UK Dapagliflozin Blocked On Appeal After Teva Readied Launch

 
• By Dean Rudge

Glenmark’s advantage for its UK generic version of AstraZeneca’s Forxiga (dapagliflozin) has quickly been snuffed out, after the originator won on appeal its request for injunctive relief.

Sandoz Admits To Widescale Infringement In Resolving US Rinvoq Patent Tussle

 
• By Dean Rudge

Sandoz has reached an agreement with AbbVie to dismiss without prejudice patent-infringement litigation involving more than 20 patents shielding the originator’s blockbuster JAK inhibitor Rinvoq.

More from Generics Bulletin

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

 
• By Dean Rudge

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 Dave Wallace

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 Dave Wallace

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.