Omlyclo (omalizumab-igec) / Celltrion - LARVOL DELTA

Emerging IgE and non-IgE targeted therapies for chronic urticaria. (PubMed, Ann Allergy Asthma Immunol) - "Dupilumab received FDA approval for antihistamine refractory chronic spontaneous urticaria (CSU) supporting the targeting of type-2 cytokines, IL-4 and IL-13, in this disease. Bruton's tyrosine kinase (BTK) inhibitors show promise, with remibrutinib receiving FDA approval and demonstrating significant reductions in UAS7 in Phase 3 trials. c-Kit (c-Kit or KIT) inhibition with barzolvolimab shows robust efficacy with sustained effects post-treatment...Although some programs have been discontinued due to safety concerns or lack of efficacy such as fenebrutinib (BTK inhibitor), THB001 (c-Kit inhibitor), EP262 (MRGPRX2 antagonist), tezepelumab (anti- TSLP), as well as lirentelimab and AK006 (Siglec-targeting agents), these studies have informed many of the other positive studies. In summary, over the last year, we have seen the CU pipeline mature with multiple Phase 3 programs and new approvals representing diverse mechanisms of action. Nevertheless, significant..."

Journal • Review • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • IL13 • IL4 • TSLP

Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR (PRNewswire) - "FDA approval of OMLYCLO (omalizumab-igec) 300 mg/2 mL solution in a single-dose prefilled syringe for subcutaneous injection expands dosing flexibility and supports tailored treatment for individual patients with certain allergic diseases."

FDA approval • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Food Hypersensitivity

Celltrion is accelerating its European market expansion for Omlyclo, a biosimilar referencing Novartis’ Xolair, after completing launches in major markets including Germany, Spain, the U.K., and France. (Korea Biomedical Review) - "Celltrion plans to continue expanding Omlyclo’s availability across Europe, focusing on customized go-to-market models according to each country’s procurement environment."

Biosimilar launch • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria

Celltrion is accelerating its expansion into Latin America’s largest pharmaceutical market with the launch of its chronic spontaneous urticaria treatment 'Omlyclo' (ingredient: omalizumab) in Brazil (Korea IT Times) - "Omlyclo is the first omalizumab biosimilar to debut in Brazil....Prior to launch, Celltrion Brazil actively promoted Omlyclo’s clinical efficacy, quality, and supply stability among local healthcare institutions and pharmaceutical procurement officials, boosting recognition and trust."

Biosimilar launch • Chronic Spontaneous Urticaria

The European Commission (EC) has granted a line extension in the European Union (EU) for Celltrion’s Omlyclo (omalizumab), Europe’s first and only omalizumab biosimilar, for the 300 mg/2ml prefilled syringe (PFS) (Businesswire) - "Omlyclo is indicated for the treatment of patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP)."

EMA approval • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria

CT-P39: An Omalizumab Biosimilar. (PubMed, Clin Drug Investig) - "The tolerability, safety and immunogenicity profiles of CT-P39 were similar to those of reference omalizumab, and switching from reference omalizumab to CT-P39 appeared to have no impact on efficacy or safety. The role of reference omalizumab in the management of allergic asthma, chronic rhinosinusitis with nasal polyps, CSU and IgE-mediated food allergy is well established and CT-P39 provides an effective alternative for patients requiring omalizumab therapy."

Journal • Review • Allergy • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatology • Food Hypersensitivity • Immunology • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • Urticaria

Budget Impact of Introducing an Omalizumab Biosimilar in 23 European Countries (ISPOR-EU 2025) - "Adopting an omalizumab biosimilar across European healthcare systems could lead to substantial cost savings, providing opportunities to expand patient access and alleviate fiscal pressure."

HEOR • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatology • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • Urticaria

Biologic relief without the price tag: the promise of omlcylo in atopic asthma and chronic spontaneous urticaria. (PubMed, Ann Med Surg (Lond)) - "Omlyclo (omalizumab-igec), the first FDA-approved biosimilar to omalizumab (Xolair) in the United States, was approved on 7 March 2025, for multiple indications including atopic asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria (CSU). While generally well tolerated, reported side effects include pruritus, vertigo, and gastrointestinal disturbances, with rare concerns regarding malignancy risk requiring further long-term evaluation. The availability of this cost-effective biosimilar marks an important milestone in expanding biologic treatment access for patients with allergic asthma and CSU."

Journal • Allergy • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatology • Food Hypersensitivity • Gastrointestinal Disorder • Immunology • Nasal Polyps • Oncology • Otorhinolaryngology • Pruritus • Pulmonary Disease • Respiratory Diseases • Sinusitis • Urticaria • Vertigo

Budget impact of introducing an omalizumab biosimilar in 23 European countries. (PubMed, J Med Econ) - "Adopting an omalizumab biosimilar in European healthcare systems could yield substantial cost savings, enhance patient access, and reduce fiscal pressure. This analysis supports biosimilars as a strategic tool for sustainable biologic therapy access in Europe."

HEOR • Journal • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatology • Immunology • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • Urticaria

…Omlyclo will be commercially available starting in Norway, with subsequent rollouts in European countries (Businesswire)

Biosimilar launch • Chronic Spontaneous Urticaria

Results from the global Phase III clinical trial of Omlyclo (CT-P39)…will be presented at a satellite symposium during the 2025 European Academy of Dermatology and Venereology (EADV) Congress (Businesswire) - "From week 24 until week 40, patients were observed without dosing. The results demonstrated that Omlyclo had comparable efficacy and safety to reference product during both treatment and off-dose periods."

P3 data • Chronic Spontaneous Urticaria

Celltrion showcases novel pipeline competitiveness, featuring OMLYCLO, ahead of European launch at EADV [Google translation] (BioNews) - "On September 18, the second day of the congress, Celltrion will host a symposium...During this session, key opinion leaders (KOLs) from across Europe will present clinical data from the 40-week global Phase 3 clinical trial of OMLYCLO, including post-treatment follow-up data, while also addressing the broader competitiveness of biosimilars....Celltrion will also unveil, for the first time, results from the global Phase 1 clinical trial of CT-P55..."

Clinical data • Chronic Spontaneous Urticaria • Immunology

…Celltrion plans to establish a dedicated promotional booth at the congress to showcase its dermatology portfolio to attending medical professionals. [Google translation] (BioNews) - "This will include OMLYCLO, which is slated for launch in Europe later this year, along with Remsima SC, Yuflyma, and Steqeyma."

Biosimilar launch • Clinical • Ankylosing Spondylitis • Chronic Spontaneous Urticaria • Crohn's disease • Immunology • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Celltrion Launches Steqeyma and Omlyclo in Australia, Accelerating Market Share Expansion (Business Korea) - "The company stated that its local subsidiary and partner Arrotex will be responsible for sales of the two products respectively, aiming to create sales synergy."

Launch non-US • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Crohn's disease • Food Hypersensitivity • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Biologic and small molecule therapies in chronic spontaneous urticaria: an update. (PubMed, Curr Opin Allergy Clin Immunol) - "The rapid increase in clinical trials in the field of CSU has already led to a significant improvement in treatment options beyond anti-IgE therapy with omalizumab in Japan and the USA, and further approvals of biologics and small molecules are expected shortly. It is expected that with a wider range of different approved therapeutic approaches, the treatment of CSU will have to be tailored to the urticaria subtype or patient profile in the future."

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Int’l journal publishes therapeutic equivalence of Celltrion’s Omlyclo [Google translation] (Pulse by Maeil Business News Korea) - P3 | N=634 | NCT04426890 | Sponsor: Celltrion | "South Korean biosimilar developer Celltrion Inc. announced on Wednesday that the results from its global Phase 3 clinical trial confirming the therapeutic equivalence of its biosimilar CT-P39 (brand name Omlyclo) at week 40 have been published in the international academic journal Clinical and Translational Allergy (CTA)....Five groups were compared in the study: 300 milligram (mg) CT-P39 monotherapy; crossover from 300 mg Xolair to 300 mg CT-P39; 300 mg Xolair monotherapy; up-dosing from 150 mg to 300 mg CT-P39; and up-dosing from 150 mg to 300 mg Xolair. Celltrion said that similar trends were observed across all treatment groups, supporting the therapeutic equivalence of the biosimilar."

P3 data • Chronic Spontaneous Urticaria

In brief: Omlyclo - an omalizumab biosimilar interchangeable with Xolair. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dermatology • Immunology • Urticaria

Efficacy and safety of CT-P39, an omalizumab biosimilar, in chronic spontaneous urticaria: 16-week follow-up study. (PubMed, Clin Transl Allergy) - P3 | "Follow-up results support the biosimilarity of CT-P39 and ref-OMA in terms of efficacy, PK, PD, QoL, safety, and immunogenicity in patients with CSU."

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Biosimilars: Breaking Down Economic Barriers to Omalizumab Access in the United States (ISPOR 2025) - "Omalizumab biosimilar’s inclusion in U.S. formularies could significantly reduce healthcare costs and expand treatment access for patients"

Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatology • Food Hypersensitivity • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • Urticaria

Celltrion wins CHMP backing for autoinjector form of Omlyclo (Korea Biomedical Review) - "Celltrion said it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a variation application to add an autoinjector (AI) formulation to its omalizumab biosimilar, Omlyclo....Omlyclo is a biopharmaceutical antibody with the same composition as the original drug, Novartis' Xolair, and it has indications that include allergic asthma and chronic idiopathic urticaria."

CHMP • Asthma • Chronic Spontaneous Urticaria

Treatment of allergic rhinitis and allergic conjunctivitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Allergic Rhinitis • Allergy • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

U.S. FDA approves Celltrion’s OMLYCLO (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR (PRNewswire) - "Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU)....The FDA approval and designation of interchangeability are based on comprehensive clinical evidence, including results from a global Phase III clinical trial involving 619 adult patients with CSU up to Week 40. Patients were randomized to receive 300 mg or 150 mg of OMLYCLO or reference product every 4 weeks."

FDA approval • Allergy • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria

Pharmacokinetics and safety of CT‑P39 via auto-injector are comparable to reference omalizumab via pre-filled syringe. (PubMed, Immunotherapy) - "Secondary endpoints were comparable between groups. CT‑P39 AI was pharmacokinetically equivalent to EU-OMA PFS following a single dose in healthy Japanese individuals; pharmacodynamics, safety, and immunogenicity were comparable."

Journal • PK/PD data

CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study. (PubMed, Allergy) - P3 | "Equivalent efficacy was observed between CT-P39 and ref-OMA, with comparable safety also evident."

Journal • P3 data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Health Canada approves Celltrion’s Omlyclo (CT-P39), the first and only omalizumab biosimilar in Canada (Businesswire) - "Celltrion today announced that Health Canada has approved Omlyclo, a biosimilar referencing Xolair. Omlyclo is approved for the treatment of adults and adolescents with chronic idiopathic urticaria (CIU), also called chronic spontaneous urticaria (CSU), adult and pediatric patients with allergic asthma, and adults with chronic rhinosinusitis with nasal polyps (CRSwNP)....Health Canada approved Omlyclo based on robust clinical evidence, including results from a global Phase III clinical trial designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Omlyclo compared to the reference product in patients with chronic idiopathic urticaria (CIU) up to Week 40. The results demonstrated the therapeutic equivalence between Omlyclo and reference omalizumab."

Canada approval • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Immunology • Urticaria