Roche Maintains ‘No Xolair Biosimilars In 2025’ As Celltrion Wins First US Omalizumab Approval

Frontrunner Celltrion Already Holds Approval In Europe, Australia, Korea

While Celltrion has scooped approval for the first biosimilar to Genentech/Novartis’ Xolair in the US – where the reference product achieved sales close to $3bn last year – Genentech’s parent Roche has stated consistently that it is not expecting to face biosimilar competition in 2025.

Question mark
• Source: Shutterstock

Celltrion is stepping up as one of the premier biosimilar players, winning approval from the US Food and Drug Administration for the first biosimilar to Genentech/Novartis’ Xolair (omalizumab) blockbuster, including a designation for interchangeability with the reference product.

The Korean firm’s Omlyclo (omalizumab-igec) has been approved for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous...

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

Samsung Bioepis Heads For Spin Out To Unlock ‘Hidden Value’

 
• By 

Samsung Biologics will retain solely its significant CDMO business, eliminating a perceived conflict of interest, as it pursues an equity spin-off for its biosimilars business Samsung Bioepis.

Amgen And Samsung Soliris Biosimilars Skirt UK Infringement On Claim Construction

 
• By 

Just days after a court in Canada barred Amgen’s Soliris biosimilar until patent expiry in 2027, a UK High Court has handed a favorable ruling to the California-based firm and Samsung Bioepis, ruling that their products do not infringe a patent shielding the branded treatment for paroxysmal nocturnal hemoglobinuria.

Formycon Hopes Stelara Biosimilar Sales To Pull Through FY2025 As Q1 Revenues Slump

 

Formycon said it predicted low earnings in the first quarter of 2025, after enjoying milestone payments last year. Now, the pressure is on the growing biosimilars portfolio to pull the company through this year.

Gedeon Richter Feels Biosimilar Model ‘Is Looking For An Equilibrium’

 
• By 

Gedeon Richter’s CEO weighed in on the pricing landscape for biosimilars as the firm admitted the market for biosimilar denosumab was set to be more crowded than it had initially anticipated.

More from Business