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

European Commission Approves Celltrion’s Stelara Biosimilar

Celltrion Joins The Likes Of Amgen, Sandoz And Stada In Europe

 
• By Adam Zamecnik

The European Commission followed the CHMP’s opinion and fully approved Celltrion’s Stelara biosimilar Steqeyma, making this the fourth approved Stelara rival in the bloc.

A photograph of EU flags
• Source: Shutterstock

The European Commission has approved Celltrion’s Steqeyma (ustekinumab) biosimilar to Johnson and Johnson’s Stelara after previously scoring a positive nod from the bloc’s European Medicines Agency, paving the way to a launch in a key global market for the South Korean player.

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

Biocon Chooses To Settle Over Eylea In US – Will Others Follow?

 
• By Dave Wallace

After Amgen’s surprise launch of the first US biosimilar to Eylea last year, expectations around competition are being further upended with the news that Biocon Biologics has struck a settlement deal with Regeneron allowing it to launch its own aflibercept rival in the second half of 2026. Will other challengers follow suit?

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.

Sandoz Attacks Amgen Over US Enbrel Exclusivity

 
• By Dave Wallace

Having failed in US patent litigation over Amgen’s Enbrel, Sandoz is taking an alternative approach in trying to get its Erelzi biosimilar to market in the US ahead of patent expiry in 2029: launching an antitrust attack against the originator for “unlawfully extending and entrenching its monopoly."

Biocon Celebrates Long-Awaited FDA Approval For Bevacizumab Biosimilar

 
• By Urtė Fultinavičiūtė

After having its facility cleared by the FDA earlier in the year, Biocon Biologics finally saw its bevacizumab biosimilar receiving approval in the US.

More from Products

Biocon Celebrates Long-Awaited FDA Approval For Bevacizumab Biosimilar

 
• By Urtė Fultinavičiūtė

After having its facility cleared by the FDA earlier in the year, Biocon Biologics finally saw its bevacizumab biosimilar receiving approval in the US.

US Bill Recap: Senate Judiciary Committee Offers Fresh Start For Reintroduced Off-Patent Drug Bills

 
• By Urtė Fultinavičiūtė

The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.

Jazz Agrees To Fork Out $145m To Resolve Most Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Jazz has agreed a nine figure settlement agreement in the US with purchasers of its Xyrem blockbuster following claims that it illegally delayed generic competition to the blockbuster treatment for narcolepsy via patent-litigation settlement agreements with several ANDA sponsors.