FDA Approves First Biosimilar to Omalizumab

The US Food and Drug Administration (FDA) has approved the first biosimilar form of omalizumab (Xolair) for the treatment of a range of allergic conditions. 

Omalizumab-igec (Omlyclo) is designed for the same four indications as its reference drug: Allergic asthma, chronic rhinosinusitis with nasal polyps, chronic unexplained hives, and food allergies.

The approval “will help broaden access to this important medicine for patients with allergic and respiratory conditions, as well as for physicians, payers and providers,” said Hetal Patel, vice president of medical affairs at Celltrion USA, which makes the drug, in a press release.

Omlyclo is indicated for patients aged 6 years and older with moderate to severe persistent asthma that does not respond to inhaled corticosteroids. A test to confirm a reaction to airborne, year-round allergens is required.

The drug also can be used as an add-on treatment for adults with chronic rhinosinusitis whose nasal polyps do not improve with nasal corticosteroids.

Patients 1 year and older can receive Omlyclo injections to reduce IgE-mediated allergic reactions to foods. Patients should avoid food allergens when taking the drug, according to the FDA.

Finally, the biosimilar agent can be used for patients with chronic spontaneous urticaria — ongoing unexplained hives — who are at least age 12 years and have not responded to H1 antihistamines. 

Omlyclo is not intended for treating other types of hives, acute bronchospasm, or status asthmaticus. It comes in single-dose, pre-filled syringes of either 75 mg/0.5 mL or 150 mg/mL.

Omlyclo has been associated with side effects, including injection site reactions, fever, headache, dizziness, and arthralgia, according to the FDA. 

The drug carries a boxed warning on its label about the risk for anaphylaxis, which can occur after the first dose or after subsequent doses, the agency said, and may have a delayed onset. The FDA advises clinicians to administer the first dose of Omlyclo “in a health care setting equipped to manage anaphylaxis.”

Brittany Vargas is a journalist covering medicine, mental health, and wellness.