Amgen’s Mvasi Biosimilar Survives Restraining Order Bid Again

US Appeals Court Denies Genentech Request For Injunction On Bevacizumab

Amgen has an open road for its Mvasi bevacizumab biosimilar after Genentech’s appeal to enjoin sales, over a notice of commercial marketing technicality, was denied. The US firm continues to weigh up patent-infringement proceedings in separate actions.

Gavels
Amgen launched Mvasi on 18 July last year after Genentech was denied an injunction • Source: Shutterstock

Amgen can continue to sell its Mvasi (bevacizumab-awwb) biosimilar after a US Court of Appeals affirmed a decision denying Avastin (bevacizumab) originator Genentech’s motions for a temporary restraining order, over Amgen’s alleged failure to comply properly with commercial marketing provisions.

The dispute refers to Amgen notifying of Genentech of its intent to begin commercial marketing for Mvasi on 6 October 2017, less than a month after receiving US

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 Legal & IP

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

 
• By 

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 

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 

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.

More from Generics Bulletin

Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
• By 

Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.

Pfizer Discusses Tariffs Amid International Slump For Oncology Biosimilars Revenue

 
• By 

Reflecting conversations across the wider pharmaceutical industry, Pfizer’s earnings call for the first quarter of 2025 focused on the sector’s response to the potential imposition of tariffs by the Trump administration.

Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.