Formycon Reports Positive Phase III Data On Ustekinumab

Company Is Looking For Marketing Partner On Stelara Biosimilar By Year End

Formycon has reported positive preliminary efficacy and safety data from the Phase III program for its FYB202 proposed ustekinumab biosimilar rival to Stelara.

Formycon logo website magnifying glass
Formycon has celebrated the latest results for its FYB202 ustekinumab candidate • Source: Shutterstock

Formycon has become the latest company to report Phase III data for a Stelara (ustekinumab) rival, revealing positive preliminary efficacy and safety data from its “VESPUCCI” trial for its FYB202 proposed biosimilar version.

The study “demonstrates the comparable efficacy of FYB202 to the reference product Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis),” Formycon said, adding that this meant the...

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 Biosimilars

Teva Brings In European Trastuzumab With Prestige BioPharma Agreement

 
• By 

Teva will now market biosimilar Herceptin in both the US and Europe, after penning an agreement with Singaporean firm Prestige BioPharma for its Tuznue rival to the monoclonal antibody to treat HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

SteinCares Deal Leads Lupin’s Ranibizumab Into Latin America

 
• By 

Lupin is planning to make inroads into the Latin American biosimilars market through a deal with local player SteinCares for a ranibizumab rival to Lucentis.

Hikma Gears Up To Enter US Biosimilars Market With Ustekinumab Nod

 
• By 

Hikma is set to make its first launch into the competitive US biosimilars market after its Bio-Thera-partnered Stelara rival, Starjemza, was approved by the FDA.

Regulatory Recap: ICH To Determine The Future Of Biosimilar Comparative Efficacy Studies

 

Generics Bulletin reviews global regulatory developments across the world.

More from Products

Advanz Allies With Pharmathen On Long-Acting Injectable

 
• By 

Advanz Pharma has announced details of a fresh alliance on long-acting injectables with Pharmathen.

Samsung Bioepis Heads For Spin Out To Unlock ‘Hidden Value’

 
• By 

Samsung Biologics will retain solely its significant CDMO business, eliminating a perceived conflict of interest, as it pursues an equity spin-off for its biosimilars business Samsung Bioepis.

Amgen And Samsung Soliris Biosimilars Skirt UK Infringement On Claim Construction

 
• By 

Just days after a court in Canada barred Amgen’s Soliris biosimilar until patent expiry in 2027, a UK High Court has handed a favorable ruling to the California-based firm and Samsung Bioepis, ruling that their products do not infringe a patent shielding the branded treatment for paroxysmal nocturnal hemoglobinuria.