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

Celltrion Approvals Set Up Denosumab Showdown In US

Korean Firm Wins FDA Nod For Third Prolia And Xgeva Biosimilars

 
• By Dave Wallace

Celltrion has become the third firm to win FDA approval for US biosimilar rivals to Prolia and Xgeva. But with multiple denosumab competitors set to launch in just a couple of months, and several more candidates on the way, the market looks likely to be another competitive one for biosimilar sponsors.

Three approved denosumab biosimilars are preparing to face off in the US (Shutterstock)

Celltrion has become the third firm to win US Food and Drug Administration approval for biosimilar denosumab rivals to Prolia and Xgeva, with the agency approving the Korean developer’s CT-P41 candidate as Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), covering all indications of the respective brands.

Denosumab is one of the major molecules set to face biosimilar competition this year. Amgen’s two reference brands currently represent...

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

Adalvo Changes Hands As EQT Takes Control

 
• By Dave Wallace

Private equity firm EQT is taking control of Alvo group B2B business Adalvo, after striking a deal to acquire a majority stake from Aztiq, the investment vehicle of founder Róbert Wessman.

Bio-Thera Matches Alvotech With US Golimumab Filing Acceptance

 
• By Dean Rudge

Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.

Samsung Bioepis Finds New US Partner For Ophthalmic Biosimilars

 
• By Dave Wallace

Samsung Bioepis has announced a fresh ophthalmic biosimilars partnership with Harrow, as the end approaches for a longstanding US commercialization alliance with Biogen on the Korean firm's Lucentis (ranibizumab) and Eylea (aflibercept) rivals Byooviz and Opuviz.

‘Our Position Has Naturally Shifted’ – How Standalone Sandoz Is Taking On Originator Abuses

 
• By Dave Wallace

As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.

More from Business

‘Our Position Has Naturally Shifted’ – How Standalone Sandoz Is Taking On Originator Abuses

 
• By Dave Wallace

As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.

ViiV Extends Voluntary License For Long-Acting Cabotegravir As HIV Treatment

 
• By Urtė Fultinavičiūtė

The Medicines Patent Pool’s extended voluntary license to produce long-acting cabotegravir to treat HIV is a win for patients living in LMICs, as the WHO updated its guidance to recommend it as an alternative treatment option.

Krka Passes €1bn Threshold In Just Six Months

 
• By Dean Rudge

Krka has reported its strongest-ever half-year results, surpassing €1bn in sales and growing EBITDA by 8%. Solid performance across most regions, particularly Eastern and Central Europe, supported stable margins and a positive full-year outlook.