Omlyclo (omalizumab-igec) / Celltrion - LARVOL DELTA

Celltrion’s 300 mg (High Dose) Biosimilar Omalizumab Approved in Australia (Pearce IP) - "Omlyclo is the only biosimilar omalizumab to have been approved in Australia, with the 75 mg/ 0.5 mL and 150 mg/1 mL PFS PBS-listed on 1 August 2025 and launched in Australia in September 2025, and the 75 mg/ 0.5 mL and 150 mg/1 mL PFP TGA-approved in August 2025 and recommended for PBS listing in April 2026."

Approval • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Food Hypersensitivity • Immunology

Celltrion’s omalizumab biosimilar Omlyclo is rapidly gaining traction in Europe, with the product now sold in 26 countries across the region (Korea IT Times) - "In Spain, Omlyclo’s market share is estimated to have surpassed 90% as of July, while sales in Italy have also exceeded the company’s initial business targets. Celltrion is seeking to build on the early momentum in major European markets. From Sept. 5 to 9, the company participated in the 2026 European Respiratory Society (ERS) Congress in Barcelona, Spain, where it highlighted Omlyclo’s product features and competitive advantages to healthcare professionals. Omlyclo is a biosimilar of omalizumab, used to treat chronic spontaneous urticaria and allergic asthma.....Celltrion plans to use these early results to expand its participation in country-specific tenders while strengthening its engagement with hospitals and healthcare professionals."

Sales • Asthma • Chronic Spontaneous Urticaria • Immunology

Celltrion…announced the launch of the 300 mg strength of Omlyclo (omalizumab), a treatment for chronic spontaneous urticaria and allergic asthma, in Europe (Businesswire) - "Omlyclo (omalizumab) 300 mg launched in key European markets including Germany, the UK and France, with rollout to expand across Europe by year-end. Omlyclo 300 mg strength available in both pre-filled syringe (PFS) and autoinjector (AI) presentations."

Biosimilar launch • Asthma • Chronic Spontaneous Urticaria • Immunology

Celltrion wins Spain with 90% share for OMLYCLO, expands EU tenders (Chosun Biz) - "The Spanish subsidiary has been supplying OMLYCLO through bids by the Catalonia, Basque Country, Asturias, and Valencia regional governments since the first half."

Commercial • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Food Hypersensitivity • Immunology

Celltrion expands biosimilar footprint in Italy with OMLYCLO gains (Chosun Biz) - "Celltrion is introducing OMLYCLO in 15 regions (states) in Italy. Of these, seven regions signed supply contracts with the State Governments. In Tuscany and Emilia-Romagna, OMLYCLO prescriptions from January to May this year were counted as surpassing XOLAIR prescriptions in the same period last year."

Commercial • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Immunology

Celltrion plans to launch Avtozma (tocilizumab) in a subcutaneous (SC) formulation and OMLYCLO (Omalizumab) in the United States in the second half (Chosun Biz)

Biosimilar launch • Allergy • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Food Hypersensitivity • Giant Cell Arteritis • Idiopathic Arthritis • Immunology • Rheumatoid Arthritis

Celltrion Pharm Launches 150mg Omriclo AI Formulation in Korea (The Asia Business Daily) - "With this launch, Celltrion Pharm has strengthened its product portfolio by adding an auto-injector (AI) type device to the existing Omriclo line-up, which had previously focused on pre-filled syringes (PFS)...The price of Omriclopen Injection 150mg has been set at 173,404 won, the same as the existing Omriclo 150mg PFS. With no price difference between the PFS and AI formulations for the same dosage, healthcare professionals can choose and prescribe the formulation according to patient condition, treatment plan, and administration environment without price constraints."

Biosimilar launch • Pricing • Allergy • Immunology

In brief: Dupilumab (Dupixent) for allergic fungal rhinosinusitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Pre-switch perceptions of omalizumab biosimilar prefilled pen in pediatric allergy: a cross-sectional survey (EAACI 2026) - "Conclusion This preliminary pre-treatment survey shows high anticipated acceptability of the prefilled pen biosimilar, with strong consensus on structured training needs and favorable expectations for simplicity, switch willingness, home confidence, and reduced administration burden. Such training fosters family autonomy, adherence, and efficiency; the model is extrapolable to other pediatric biologics."

Clinical • Late-breaking abstract • Allergy • Immunology

Short-term tolerance of omlyclo, the omalizumab biosimilar (EAACI 2026) - "No anaphylactic reactions occurred after the first administration of Omlyclo®. Conclusion Short-term tolerance to switching from the originator drug to the biosimilar Omlyclo® was excellent overall, with only mild adverse events observed in a small proportion of patients."

Late-breaking abstract • Immunology

Real-World Transition from Reference Omalizumab to Biosimilar Omlyclo in Patients with Chronic Urticaria: A Single-Center Descriptive Study (EAACI 2026) - "Early findings further indicate sustained patient-reported treatment satisfaction following the switch. Ongoing longitudinal analyses will provide long-term UCT comparisons to further substantiate these early-phase findings."

Clinical • Late-breaking abstract • Real-world • Real-world evidence • Immunology

Efficacy of omalizumab in patients with chronic spontaneous urticaria with and without angioedema: a post hoc analysis of a double-blind, randomized, phase 3 study of omalizumab biosimilar CT-P39 (EAACI 2026) - P3 | "Conclusion OMA effectively reduced the frequency of AE, which persisted for up to 16 weeks following treatment discontinuation. The efficacy of OMA in CSU was independent of the presence or absence of AE."

Clinical • P3 data • Retrospective data • Immunology

Quality of life outcomes of omalizumab biosimilar CT-P39 compared to reference omalizumab in patients with chronic spontaneous urticaria: a post hoc analysis of a double-blind, randomized, phase 3 study (EAACI 2026) - P3 | "Conclusion CT-P39 improved QoL across all domains of the DLQI and CU-Q 2 oL at a comparable level to ref-OMA and showed clinically meaningful improvements in QoL. These results support its use as a valid treatment option for patients with CSU."

Clinical • HEOR • P3 data • Retrospective data • Immunology

Predictors of response to omalizumab treatment in patients with chronic spontaneous urticaria: a post hoc analysis of a double-blind, randomized, phase 3 study (EAACI 2026) - P3 | "In the quantile analyses, patients with longer disease duration and the quartile of the lowest IgE level (total IgE < 34.2 IU/mL) were less likely to achieve complete response at W12 ( Figure 1 ). Conclusion Shorter disease duration, higher total IgE level and lower ISS7 at baseline were positively associated with complete response at W12 during omalizumab treatment in patients with CSU."

Clinical • P3 data • Retrospective data • Immunology

Omlyclo reached market shares of 98 percent in Denmark, 80 percent in Spain and 70 percent in the Netherlands within about four months (Korea Biomedical Review) - "Additional tender wins in major European countries are expected to support sales growth in the second half."

Commercial • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria

PBAC Recommends PBS Reimbursement for Biosimilars to Adalimumab (High Concentration), Omalizumab (PFP) & Ustekinumab (Pearce IP) - "At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement of the following biosimilars: Amgen’s Amgevita (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP); Celltrion’s Yuflyma (adalimumab) in 20mg/0.2ml PFS; Celltrion’s Omlyclo (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP; Sandoz’s Ardelya (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS; Amgen’s Wezlana (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS and 130 mg in 26 mL solution for IV infusion."

Reimbursement • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Crohn's disease • Hidradenitis Suppurativa • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

The First Biosimilar for Biologics in Allergy: CT-P39 (Omlyclo-Omalizumab-Igec) Is Available for Asthma, Chronic Spontaneous Utricaria, and Chronic Rhinosinusitis With Nasal Polyps. (PubMed, Allergy) - No abstract available

Journal • Allergy • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis

Celltrion wins Europe tenders, grows OMLYCLO share in urticaria market (Chosun Biz) - "In Italy, the company won bids in 10 out of a total of 14 State Governments-level tenders and began supplying....In the United Kingdom, it secured supply rights across all four administrative regions, including England, through a National Health Service (NHS) tender....Germany is also seeing rapid early traction. Launched in September last year, OMLYCLO reached a double-digit market share within a month of sales and has maintained its growth since....In Northern Europe, tender-based results stand out. In Denmark, after launching four months earlier than initially planned, it secured exclusive supply status and posted a 98% share as of January this year....Spain and the Netherlands are also seeing continued share gains."

Commercial • Chronic Spontaneous Urticaria

Celltrion Pharm said Wednesday it has launched Omlyclo Pre-Filled Syringe (PFS) Injection (omalizumab) 300 mg in the Korean market, a treatment for allergic diseases. (Korea Biomedical Review) - "The product is also more affordable. The 300 mg PFS costs 252,200 won ($167), about 27 percent less than two 150 mg PFS doses (346,808 won). Patients needing 300 mg now get the right dose at a better price."

Biosimilar launch • Pricing • Asthma • Immunology • Urticaria

Celltrion launches omalizumab biosimilar Omlyclo in Brazil, secures early tender win (Korea Biomedical Review)

Biosimilar launch • Asthma • Chronic Spontaneous Urticaria

Celltrion said on the 27th that it received product approvals for OMLYCLO and Eydenzelt from Japan’s Ministry of Health, Labour and Welfare (Chosun Biz) - "OMLYCLO is the first XOLAIR biosimilar approved in Japan. It was approved for all original indications, including bronchial asthma, chronic spontaneous urticaria, and seasonal allergic rhinitis. Eydenzelt was approved for ophthalmic indications such as macular degeneration and diabetic macular edema."

Japan approval • Allergic Rhinitis • Asthma • Chronic Spontaneous Urticaria • Diabetic Macular Edema • Macular Degeneration

Food and Drug Administration Regulation of Biosimilar Products- Improving Affordability of Biologics for Patients with Asthma and Allergic Diseases. (PubMed, J Allergy Clin Immunol) - "This review discusses FDA regulation of biologics and biosimilars, the recent approval of the first omalizumab biosimilar, and the evolving regulatory landscape for biosimilars to decrease the costs of development while ensuring the efficacy and safety of biosimilars. The approval of biosimilars for allergic diseases and asthma treatment is expected to significantly improve accessibility and affordability of these therapies, providing healthcare providers and patients with confidence in high-quality, cost-effective treatment options for patients with severe and refractory asthma and allergic conditions."

Journal • Review • Allergy • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar (clinicaltrials.gov) - P=N/A | N=225 | Recruiting | Sponsor: Celltrion HealthCare France

New trial • Asthma • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pulmonary Disease • Respiratory Diseases • Urticaria

Systemic Treatments for Chronic Spontaneous Urticaria: Anti-IgE and Beyond. (PubMed, J Allergy Clin Immunol Pract) - "Current standard of care includes nonsedating H1-antihistamines and omalizumab, which targets peripheral blood IgE and downregulates mast cell and basophil IgE receptors...Dupilumab received FDA approval for H1-antihistamine-refractory CSU, supporting targeting type 2 cytokines, IL-4 and IL-13. Most recently, a Bruton's tyrosine kinase inhibitor (BTKi), remibrutinib, demonstrated significant reductions in Urticaria Activity Score over 7 days in phase 3 trials, leading to FDA approval. Newer c-Kit (cKit or KIT) inhibitors have also shown efficacy in CSU and CIndU, with barzolvolimab showing sustained efficacy post-treatment...Some drugs have been halted in development because of safety concerns, such as fenebrutinib (BTKi), THB001 (Larvol; c-Kit inhibitor), and EP262 (MRGPRX2 antagonist), whereas others, targeting the alarmin thymic stromal lymphopoietin (tezepelumab), the Th2 cytokine IL-5 (mepolizumab) and its receptor IL-5R (benralizumab), as well as lirentelimab..."

Journal • Review • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • IL13 • IL4 • IL5 • SIGLEC8 • TSLP • TYK2

Celltrion said on the 4th that OMLYCLO, which treats asthma and urticaria, is expanding its market in Spain (Chosun Biz) - "Celltrion's Spanish subsidiary was selected as the No. 1 supplier in a public tender in Catalonia at the end of last year. Catalonia is considered the largest supply region locally due to its high population density. OMLYCLO is also set to be supplied to the Basque Country. The company said it was chosen as the top bidder in a Basque Country public tender as well and signed a supply contract on the 1st of last month."

Commercial • Asthma • Immunology • Urticaria