FDA Approves First Biosimilar of Xolair

The FDA has approved Celltrion’s biosimilar Omlyclo (omalizumab-igec), which references Xolair (omalizumab), which is marketed by Genentech and Novartis. It is approved as an interchangeable biosimilar to treat patients with moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).

Omlyclo is available as 75 mg/0.5 mL and 150 mg/mL solutions in a single-dose prefilled syringe and is interchangeable with the reference product for all indications. Omlyclo is administered subcutaneously for all indications, but it has different dose instructions for each indication.

“The interchangeability designation of Omlyclo reinforces confidence among physicians and patients that there is no decrease in effectiveness or increase in safety risk associated with switching between Omlyclo and the reference product,” Hetal Patel, vice president of Medical Affairs at Celltrion USA, said in a news release.

No word is available yet on when Omlyclo will be available or what the price will be.

The current list price of Xolair is approximately $30,000 to $60,000 annually. For those patients who did have out-of-pocket costs, 90% paid between $5 and $1,475 per month, according to the product website.

The approval and interchangeability designation are based on clinical evidence, including results from a global phase 3 clinical trial involving 619 adult patients with chronic spontaneous urticaria up to week 40. Patients were randomly assigned Xolair or Omlyclo every 4 weeks. At week 12, patients who received Omlyclo were continued on with that therapy. The remaining patients were randomly assigned to receive Omlyclo or Xolair

The results demonstrated the comparable efficacy and safety of Omlyclo to the reference product during both treatment and off-dose periods.

Side effects from Omlyclo include injection site reactions, fever, headache, dizziness, and arthralgia. In addition, Omlyclo has a boxed warning for anaphylaxis, which can be life-threatening. The reaction can occur after the first dose or after many doses. Because of the risk of anaphylaxis, therapy should be initiated in a healthcare setting.

Xolair and Omlyclo are designed to target immunoglobulin E (IgE), which is an antibody that is produced by the immune system. These antibodies can overreact, causing an allergic reaction. By blocking IgE, they can minimize and reduce the inflammatory process.