The FDA approved omalizumab-igec (Omlyclo) as the first biosimilar for omalizumab (Xolair) and the first for any respiratory condition in the U.S., drugmaker Celltrion announced Monday.
The anti-immunoglobulin E (IgE) antibody biosimilar met requirements to be considered interchangeable with the Xolair-branded version for a number of indications:
- Moderate to severe persistent asthma inadequately controlled by inhaled corticosteroids in adults and children ages 6 years and older with a positive skin test or in vitro reactivity to a perennial aeroallergen
- Chronic rhinosinusitis with nasal polyps in adults with inadequate response to nasal corticosteroids, as add-on maintenance treatment
- IgE-mediated food allergy in adults and children at least 1-year-old for the reduction of allergic reactions, including anaphylaxis, that occur with accidental exposure while maintaining allergen avoidance
- Chronic spontaneous urticaria that is symptomatic despite H1 antihistamine treatment in adults and adolescents ages 12 years and older
“The approval of Omlyclo could have a meaningful impact for the medical community and patients, offering a high-quality and affordable treatment option, while reducing the burden of healthcare costs,” said Thomas Nusbickel, chief commercial officer at Celltrion USA, in a statement.
The biosimilar was not approved for other forms of urticaria, nor for acute or emergency treatment of bronchospasm, status asthmaticus, or allergic reactions like anaphylaxis.
The approval was based on results from a phase III trial that confirmed the bioequivalence of the biosimilar, formerly known as CT-P39, to omalizumab in patients with chronic spontaneous urticaria. The trial randomized 619 patients in six countries to double-blind treatment with 150 or 300 mg of either omalizumab or biosimilar. For the primary endpoint, change from baseline in weekly itch severity score (ISS7) at week 12 showed a nonsignificant difference between the two biologics (0.77 at 300 mg, 95% CI -0.37 to 1.90). The two also had similar safety, pharmacokinetics, and immunogenicity, all meeting the pre-defined equivalence criteria.
As with omalizumab, prescribing information warns about the risk of anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, or angioedema of the throat or tongue. These events have been reported as soon as the first dose and as late as beyond 1 year after beginning regularly administered treatment. Physicians are advised to initiate treatment with both biologics in a healthcare setting under close observation.
The most common adverse reactions varied by indication and age.
For asthma in patients ≥12 years, arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache were reported in at least 1% of patients. For asthma in children ages 6 to 11 years, nasopharyngitis, headache, pyrexia, upper abdominal pain, streptococcal pharyngitis, otitis media, viral gastroenteritis, arthropod bites, and epistaxis were reported in at least 3%.
For chronic rhinosinusitis with nasal polyps, at least 3% of adults reported headache, injection site reactions, arthralgia, upper abdominal pain, and dizziness. At least 3% of food allergy patients reported injection site reactions and pyrexia. In chronic spontaneous urticaria, at least 2% of patients reported nausea, nasopharyngitis, sinusitis, upper respiratory tract infections (viral and non-viral), arthralgia, headache, and cough.
The approval covered two doses matching those of omalizumab — a 75 mg/0.5 mL injection and a 150 mg/mL injection — both to be administered in single-dose prefilled syringes for subcutaneous use.
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