What’s Next? Five Things To Look Out For In September

Another US Ustekinumab Approval Awaits; Generic Competition To Sprycel On The Horizon

Generics Bulletin previews the most noteworthy and anticipated events for September 2024.

What's Next Image
• Source: Norstella/Citeline

This month, the US Food and Drug Administration is set to issue its decision on Formycon’s FYB202 proposed biosimilar to Stelara (ustekinumab), teeing up a potential launch in April 2025.

Alongside partner Fresenius Kabi, Formycon announced the submission of its biosimilar ustekinumab biologics license application towards the end of last...

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

Reshaped Xbrane Allies With OneSource For Commercial Biosimilar Manufacturing

 
• By 

Xbrane Biopharma is partnering with India’s OneSource Specialty Pharma to manufacture its biosimilars, including its much-delayed ranibizumab product Ximluci. The move follows a SEK240m funding round and strategic refocus on commercialization after divesting key R&D assets to Alvotech.

Regeneron Monitoring Eylea Biosimilar Closely Following Innovative Setbacks

 
• By 

Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.

Stelara Biosimilar Sees Stada’s Specialty Sales Start Strong In Q1

 
• By 

Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.

Formycon Snatches Brazilian Approval For Lucentis Biosimilar

 

Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.

More from Products

Generic Drug Office’s Policy Staff Returning To US FDA

 

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Stelara Biosimilar Sees Stada’s Specialty Sales Start Strong In Q1

 
• By 

Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.

Formycon Snatches Brazilian Approval For Lucentis Biosimilar

 

Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.