Dong-A ST Achieves Therapeutic Equivalence With Stelara Biosimilar

Company Aims To Submit EU and US Marketing Authorization During H1

Dong-A has achieved therapeutic equivalence for its ustekinumab biosimilar candidate DMB-3115 in clinical studies and now plans to file for marketing authorization for the product in both the EU and US.

Graphic reading 'Clinical Trial'
• Source: Shutterstock

A global Phase III trial of 605 patients across the US and Europe has demonstrated therapeutic equivalence between Stelara (ustekinumab) and Dong-A ST’s biosimilar candidate DMB-3115.

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 Products

Cardinal Looks Ahead To A New Decade For US Biosimilars

 
• By 

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

 

Generics Bulletin reviews global regulatory developments across the world.

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

 
• By 

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 

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 

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 

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 

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.