Omlyclo Biosimilar Shows Comparable Efficacy to Xolair for CSU

A recent follow-up study confirms that Omlyclo, a biosimilar to Xolair (omalizumab), demonstrates similar efficacy, pharmacokinetics, pharmacodynamics, safety, and immunogenicity in the treatment of chronic spontaneous urticaria (CSU). This pivotal research, conducted as part of a phase 3 clinical trial, provides robust evidence supporting the interchangeability of Omlyclo, developed by Celltrion Healthcare, with Xolair, which has been a standard treatment for CSU since its approval in 2014.

The phase 3 trial, ClinicalTrials.gov ID NCT04426890, included a comprehensive analysis of 1,198 patients aged 12 to 75, who were assigned to receive either Omlyclo or Xolair over a 12-week treatment period. Results showed comparable improvements in itch severity, urticaria activity, and hives severity across the treatment groups, with no significant treatment-emergent adverse events leading to discontinuation or death.

The follow-up study, which assessed outcomes over a 16-week off-treatment period, revealed that improvements in itch severity scores (ISS7) were maintained, although there was a gradual decrease noted in scores after the 24-week treatment period. Importantly, the proportion of patients requiring additional nonsedating H1-antihistamines as rescue therapy remained low, suggesting sustained efficacy.

Dr. Christopher Grattan, lead author of the study and a professor at the University of Kent, stated, “The follow-up findings reinforce Omlyclo’s status as a validated biosimilar for Xolair, underscoring its potential to offer a cost-effective alternative for patients with CSU.”

The approval of Omlyclo as the first interchangeable biosimilar was based on its ability to provide similar efficacy and safety to Xolair without the financial burden associated with the latter. As highlighted in the study, Omlyclo's introduction into the market is expected to increase patient access to effective treatment options for CSU, particularly in light of the high costs associated with biological therapies.

Celltrion received FDA approval for Omlyclo on March 10, 2025, marking a significant milestone in the field of biosimilars. This designation allows for the substitution of Omlyclo for Xolair without the need for additional clinical justification, which could streamline treatment protocols and enhance patient compliance.

In the context of rising healthcare costs, the emergence of biosimilars like Omlyclo is viewed as a critical development that can alleviate the financial burden on patients while maintaining high standards of care. As the healthcare landscape continues to evolve, the role of biosimilars is increasingly recognized as vital for promoting affordability and accessibility in therapeutic options.

In conclusion, the findings from the follow-up study not only confirm the efficacy and safety of Omlyclo in treating CSU but also pave the way for broader acceptance and utilization of biosimilars in clinical practice. As further studies and real-world data become available, the long-term impact of Omlyclo on patient outcomes and healthcare costs will be closely monitored by both healthcare providers and patients alike.