1. Generics Bulletin
  2. >>Products

FDA Makes It 50 With Accord Trastuzumab Biosimilar Approval

Henlius-Partnered Hercessi Rival To Herceptin Becomes 50th US Biosimilar And First For Accord

 
• By Dave Wallace

The US FDA has marked a milestone with the approval of the country’s 50th biosimilar, in the form of Henlius and Accord BioPharma’s Hercessi trastuzumab rival to Herceptin.

Number 50 in red, white and blue
The FDA has approved its 50th biosimilar • Source: Shutterstock

A milestone in biosimilar approvals has been achieved by the US Food and Drug Administration, with the agency approving the country’s 50th biosimilar, in the form of Henlius and Accord BioPharma’s partnered Hercessi (trastuzumab-strf) rival to Herceptin.

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 Products

Cardinal Looks Ahead To A New Decade For US Biosimilars

 
• By Dave Wallace

In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.

Regulatory Recap: UK To Capture £1bn Savings With Framework For Best-Value Biologics

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

Aurobindo Plots Rivaroxaban Roll-Out As FDA Approves 2.5mg Strength ANDA

 
• By Dean Rudge

Aurobindo is set to join Lupin by competing against Johnson/Bayer’s blockbuster blood thinner Xarelto (rivaroxaban) 2.5mg tablets.

Tevogen Launches Generics-Focused Initiative As Trump Eyes Pharma Tariffs

 
• By Adam Zamecnik

As the Trump Administration continues to send ripples across industries, Tevogen has launched a new generic drugs-focused endeavor that plans to reshore production to the US.

More from Generics Bulletin

Tevogen Launches Generics-Focused Initiative As Trump Eyes Pharma Tariffs

 
• By Adam Zamecnik

As the Trump Administration continues to send ripples across industries, Tevogen has launched a new generic drugs-focused endeavor that plans to reshore production to the US.

Coherus Marks Exit From Biosimilars By Completing Udenyca Divestment

 
• By Dave Wallace

Coherus has officially marked its exit from biosimilars by completing the divestment of its Udenyca pegfilgrastim franchise. Meanwhile, buyer Accord BioPharma has set out how it expects to benefit not only from a growing asset but also from the Coherus personnel that have moved over.

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.