1. Generics Bulletin
  2. >>Products
  3. >>Biosimilars

Bio-Thera Delivers Positive Phase III Results For Stelara Biosimilar

Hikma Holds Exclusive Rights To Commercialize The Ustekinumab Product In The US

 
• By Chloe Kent

Bio-Thera has announced positive Phase III results for its ustekinumab biosimilar candidate BAT2206, demonstrating that the product is highly similar to originator Stelara in patients with moderate to severe plaque psoriasis. 

Ustekinumab vial
Ustekinumab is used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis • Source: Shutterstock

Chinese biosimilar developer Bio-Thera Solutions Ltd. has announced positive results from its Phase III study into its asset BAT2206, a proposed biosimilar to Stelara (ustekinumab). The results demonstrated that BAT2206 is highly similar to Stelara in patients with moderate to severe plaque psoriasis.

The global, multi-center, randomized, double-blind, parallel-arm Phase III study compared the efficacy, safety, immunogenicity and pharmacokinetics of BAT2206 and Stelara in 556 plaque psoriasis patients

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 Biosimilars

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Amgen Biosimilars Continue Surge Ahead Of Imminent Denosumab Competition

 
• By Dean Rudge

Thanks to its efficient development pipeline, sales of Amgen’s biosimilars neared $750m for the first three months of the year, offering some comfort as the firm gears up for the loss of exclusivity for its denosumab franchise.

Tofidence And Tariffs - Organon Discusses Exposure Of Its Biosimilars Business

 
• By Dave Wallace

During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

More from Products

Lupin Touts FDA Approval For Generic Tolvaptan With 180-Day Exclusivity

 
• By Urtė Fultinavičiūtė

After receiving a favorable court ruling last year, Lupin has secured its first-place spot for generic tolvaptan tablets in the US.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

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.”