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

Medicines For Europe Sets Out Trade Priorities

 
• By Dave Wallace

As Medicines for Europe gears up for a pair of conferences in Brussels next week, the organization has set out trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing, in a seminar with representatives from the European Commission and member states.

Celltrion Reinforces Commitment To UK Biosimilars Market With New HQ

 
• By Dave Wallace

Celltrion has reinforced its commitment to the UK by opening a new central operations hub in Uxbridge, while acknowledging that “major questions over the attractiveness of the market” need to be addressed to encourage development and ensure a sustainable environment for UK biosimilars.

Pipeline And Parent: Meitheal CEO Shea Talks Paclitaxel And What’s Next

 
• By Dean Rudge

In an exclusive interview, Meitheal Pharmaceuticals CEO Tom Shea discusses the company’s oncology strategy following the recent launch of generic Abraxane, alongside discussion of complex injectables, the biosimilars pipeline, and how $300m in backing is fueling the company's next phase of growth.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

More from Business