1. Generics Bulletin
  3. >>Biosimilars

Celltrion Bags FDA Approval For High-Concentration Humira Rival

Yuflyma, Ninth US Adalimumab Biosimilar, Will Be Marketed Directly By Korean Firm

 
• By Dave Wallace

Celltrion USA has won US FDA approval for its Yuflyma 100mg/ml adalimumab biosimilar, making it the third high-concentration version approved in the US and the ninth Humira rival overall.

Red 100 emoji
Celltrion has obtained approval for a 100mg/ml adalimumab biosimilar • Source: Shutterstock

Celltrion USA has notched up a further US biosimilar registration after receiving US Food and Drug Administration approval for its Yuflyma (adalimumab-aaty) 100mg/ml high-concentration and citrate-free rival to Humira.

The approval comes as a second wave of adalimumab biosimilars are preparing to hit the US market around the start of July (see sidebar), following Amgen’s launch of its Amjevita (adalimumab-atto) debut version earlier this year

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

‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

 
• By Dave Wallace

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

Biocon Biologics Plans To Slow Down After Five Planned Near-Term Biosimilar Launches

 
• By Urtė Fultinavičiūtė

With a lineup of five high-value biosimilars in the wings, Biocon Biologics may be more selective going forward and plans to take a one product per year approach.

Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
• By Dave Wallace

Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.

Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 
• By Urtė Fultinavičiūtė

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.

More from Products