Celltrion’s OMLYCLO: First Interchangeable Biosimilar to Xolair Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved OMLYCLO® (omalizumab-igec), a biosimilar developed by Celltrion, as the first and only biosimilar with an interchangeability designation referencing XOLAIR® (omalizumab). This approval marks a significant step towards increasing patient access and potentially lowering healthcare costs for individuals with allergic and respiratory conditions.

What is OMLYCLO and Why is Interchangeability Important?

OMLYCLO is a biosimilar to XOLAIR, a medication used to treat moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU). Biosimilars are highly similar, but not identical, copies of already-approved biologic drugs. The “interchangeability” designation is crucial because it allows pharmacists to substitute OMLYCLO for XOLAIR without the need for a fresh prescription from a physician, similar to how generic drugs are substituted for brand-name drugs. This simplifies treatment for patients and can lead to cost savings.

Clinical Evidence Supporting Approval

The FDA’s approval and interchangeability designation were based on comprehensive clinical evidence, including a Phase III clinical trial involving 619 adult patients with CSU. The trial demonstrated that OMLYCLO had a comparable efficacy and safety profile to the reference product, XOLAIR. Specifically, the study involved patients randomized to receive either 300 mg or 150 mg of OMLYCLO or XOLAIR every four weeks for up to 40 weeks. A switch at week 12 allowed patients initially treated with XOLAIR to be re-randomized to either continue with XOLAIR or transition to OMLYCLO, further validating the biosimilar’s performance. Celltrion USA

Impact on Patients and Healthcare System

The availability of OMLYCLO is expected to broaden access to omalizumab for patients who may benefit from this treatment. Hetal Patel, Vice President of Medical Affairs at Celltrion USA, stated that the approval will help patients with allergic and respiratory conditions, as well as physicians, payers, and providers. Celltrion USA The interchangeability designation reinforces confidence in the safety and effectiveness of switching between OMLYCLO and XOLAIR.

Celltrion’s Expansion in the Biosimilar Market

Celltrion has been actively expanding its presence in the European biosimilar market. In May 2024, the company announced the approval of Omniclo (CT-P39), a biosimilar to Xolair, in Europe, making it the first approved Xolair biosimilar on the continent. Asiae.co.kr The original drug, Xolair, generated global sales of approximately $3.9 billion (5 trillion KRW) in 2023. Asiae.co.kr Beyond Europe and the U.S., Celltrion has also submitted approval applications in South Korea and Canada.

Future Outlook

The approval of OMLYCLO in the U.S. And Omniclo in Europe represents a significant milestone for Celltrion and the biosimilar industry. As more biosimilars enter the market, it is anticipated that competition will drive down costs and improve access to essential medications for a wider range of patients. PharmExec