1. Generics Bulletin

Amgen Cleared Again On Kanjinti As Trial Looms

Denial Of Preliminary Injunction Upheld On Appeal

 
• By Dean Rudge

With an infringement trial set to begin next month, Amgen can continue to sell its Kanjinti trastuzumab biosimilar in the US after a Court of Appeals shot down originator Genentech's latest bid to block sales of the rival to its Herceptin blockbuster.

Gavel
Amgen launched biosimilar trastuzumab in the US last July • Source: Shutterstock

Amgen can continue marketing for now the firm’s Kanjinti (trastuzumab-anns) biosimilar in the US following a Court of Appeals ruling, ahead of a district court jury trial on trastuzumab intellectual property scheduled for next month.

Genentech, which markets the Herceptin original, has seen an appeals court affirm without comment a prior district court ruling denying the firm’s bid for a

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
Start Free Trial

Already a subscriber?

More from Legal & IP

After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”

Viatris Pens Aprepitant Settlement Agreement After Kabi Loses Initial Patent Case

 
• By Dean Rudge

Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.

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.

More from Generics Bulletin