Hikma Gears Up To Enter US Biosimilars Market With Ustekinumab Nod

Bio-Thera-Partnered Starjemza Becomes Eighth Stelara Rival To Be Approved By FDA

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.

Hikma will have one of eight approved Stelara biosimilars (Shutterstock)
Key Takeaways
  • Hikma is set to enter the US biosimilars market after its Bio-Thera-partnered Starjemza (ustekinumab-hmny) rival to Stelara was approved by the US FDA.

Hikma is getting ready to make its first launch into the US biosimilars market after receiving US Food and Drug...

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

Biocon’s Denosumab Biosimilar Approved In The UK As Competition Grows In Europe

 

Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.

Pertuzumab Leader Henlius Receives EU Accreditation For Production Lines

 
• By 

Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.

Alvotech Boosts Packaging Abilities With Ivers-Lee Acquisition

 
• By 

Alvotech has acquired long-time partner Ivers-Lee to expand its in-house capacity for assembly and packaging ahead of key planned biosimilar launches in 2025, strengthening operational control and supporting global growth.

Bakers And Fishermen: How Biosimilars Manufacturers Are Bridging The Skills Gap

 
• By 

At Medicines for Europe’s annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap.

More from Business

China’s Qilu Looks To US Hospitals Market With Sagent Injectables Collaboration

 
• By 

Sagent and Qilu will look to enhance access, reduce treatment costs, and strengthen supply chains after striking an alliance for a portfolio of the Chinese firm’s complex injectables.

Who’s Hired? Stada Picks Biogen’s Biosimilars Chief Henshaw To Lead Specialty Segment

 
• By 

Stada has appointed former Biogen biosimilars head Ian Henshaw as the new leader of its Specialty segment. Meanwhile, Craig Burton has left the AAM for Fresenius Kabi, Australia's GBMA is looking for a new chief executive, and Speranza, Outlook and EuroAPI have announced new appointments.

Three’s A Crowd? Celltrion Launches Denosumab In US

 
• By 

A third pair of Prolia and Xgeva rivals has now been launched in the US, with Celltrion throwing its hat into the ring after denosumab launches by Sandoz and Fresenius Kabi. But this is only the beginning for what is shaping up to be another highly competitive biosimilars market.