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

Alvotech Petitions FDA To Deny Interchangeability For Rival Stelara Biosimilars

Urges Agency Not To Approve Samsung Bioepis And Sandoz’s Pyzchiva As Interchangeable

 
• By Dave Wallace

In a citizen petition to the FDA, Alvotech has called on the US agency to refrain from approving as interchangeable certain Stelara biosimilars that use a different cell line to its own ustekinumab product – including the Pyzchiva version set to be brought to market by Samsung Bioepis and Sandoz.

Alvotech is calling on the FDA to deny interchangeability for certain ustekinumab biosimilars (Shutterstock)

In a move aimed at influencing the US Food and Drug Administration’s approval decisions for its biosimilar rivals, Alvotech has petitioned the agency in an attempt to prevent certain other Stelara (ustekinumab) biosimilar developers from gaining a coveted interchangeability designation for their products, based primarily on sialyation differences between ustekinumab products developed using different types of cell lines.

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

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By Dave Wallace

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

Samsung Bioepis Grows After US Launches

 
• By Dave Wallace

Samsung Bioepis has revealed first-quarter figures that reflect recent launches driving growth for the Korean biosimilars developer.

French Body Welcomes Call For Greater Uptake

 
• By Dave Wallace

French generics and biosimilar body Gemme has welcomed a call from the country’s audit court to improve uptake for off-patent medicines.

Celltrion Celebrates Interchangeability Designation For Humira Biosimilar In The US

 
• By Urtė Fultinavičiūtė

Celltrion’s adalimumab biosimilar was crowned as interchangeable by the FDA, at a time when the future of the designation is unknown.

More from Policy & Regulation

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.

As US Launches Pharma Probe, AAM Warns Tariffs ‘Will Only Amplify Problems’

 
• By Dave Wallace

News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe.