Omlyclo (omalizumab-igec) / Celltrion - LARVOL DELTA

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

Biosimilars: The Key to Lowering Access Barriers to Omalizumab Across Europe (ISPOR-EU 2024) - "When compared with dupilumab, mepolizumab, and tezepelumab, the expected annual savings would average 43%, with a maximum of 75%. The disparities highlighted in this study underscore the need for improvement in access to omalizumab across Europe. This study highlights the need for comprehensive policy reforms and the introduction of omalizumab biosimilar to ensure equitable access to omalizumab across Europe, enhancing patient care and potentially solving shortage issues and expanding treatment options for off-label indications su ch as urticarial vasculitis and food allergy."

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

PHARMACOKINETICS AND SAFETY OF CTP39 VIA AUTOINJECTOR TO REFERENCE OMALIZUMAB IN HEALTHY JAPANESE SUBJECTS (ACAAI 2024) - "The PK similarity of CT-P39 AI to ref-omalizumab PFS was demonstrated in healthy Japanese subjects by primary PK endpoints. CT-P39 AI was well tolerated with a safety and immunogenicity profile comparable to that of ref-omalizumab PFS. Table 1."

Clinical • PK/PD data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

CT-P39 COMPARED TO REFERENCE OMALIZUMAB IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA; 40- WEEK RESULTS (ACAAI 2024) - "CT-P39 showed comparable efficacy and safety to refOMA during both treatment and off-dose periods. A switch from refOMA to CT-P39 from Week 12 showed comparable efficacy and safety to continuing treatment with ref-OMA."

Clinical • Late-breaking abstract • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Celltrion Pharm's 3 biosimilars 24-36% cheaper than originals in Korea (Korea Biomedical Review) - "Celltrion Pharm said it has launched three biosimilar products in Korea following the Ministry of Health and Welfare’s pricing notification last Sunday....This biosimilar is prescribed for allergic asthma and chronic idiopathic urticaria, with reimbursed prices set at 102,960 won ($76.78) for the 75 mg dose and 195,079 won for the 150 mg dose— approximately 28 percent lower than the original product....The reimbursed price of the prefilled syringe (PFS) form will be available at 1,298,290 won for the 45 mg/0.5 mL dose and 1,342,320 won for the 90 mg/1 mL dose—about 26 percent less than the price of the original drug....Eydenzelt, approved in Korea in May, is indicated for the treatment of macular degeneration and visual impairment caused by macular edema due to retinal vein occlusion. The reimbursed price for the 11.32 mg/0.283 mL dose is set at 330,000 won, which is approximately 34 percent cheaper than the original product."

Reimbursement • Asthma • Crohn's disease • Immunology • Inflammatory Bowel Disease • Macular Degeneration • Macular Edema • Psoriasis • Psoriatic Arthritis • Retinal Vein Occlusion • Ulcerative Colitis

Celltrion's Xolair biosimilar secures approval in UK (Korea Biomedical Review) - "Celltrion said its Xolair biosimilar, Omlyclo (omalizumab), which was called CT-P39 in the developing stage, received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) as the first biosimilar of its kind....The approval is based on positive results from global phase 3 clinical trials, which demonstrated the efficacy and safety of Omlyclo compared to the original biologic drug, Xolair. The trials included 619 patients with chronic spontaneous urticaria across six European countries....With this approval, Omlyclo is now authorized for the treatment of allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria."

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

Celltrion scores domestic nod for Xolair biosimilar (Korea Biomedical Review) - "Celltrion has received approval for its Xolair biosimilar, Omlyclo (omalizumab), which was called CT-P39 in the developing stage, from the Korean regulator. Celltrion said Monday that it won the nod from the Ministry of Food and Drug Safety for Omlyclo Prefilled Syringe Injection. The approval comes one year after the company applied for it in June 2023....Celltrion demonstrated the equivalence and safety of Omlyclo in the phase 3 clinical trial in six European countries totaling 619 patients."

Korea approval • Chronic Spontaneous Urticaria • Immunology

Omlyclo: “The committee confirmed that all issues previously identified in this application had been addressed”; Asthma (European Medicines Agency) - CHMP Final Minutes of the meeting on 18- 21 Mar 2024: “The committee adopted a positive opinion recommending the granting of a marketing authorisation by consensus together with the CHMP assessment report and translation timetable”

CHMP • Asthma • Immunology

Comparable Efficacy and Pharmacodynamic Results of CT-P39 to Reference Omalizumab in Patients with Chronic Spontaneous Urticaria (EAACI 2024) - "Conclusion The efficacy and PD of CT-P39 were similar to ref-OMA up to Week 24, including in patients who switched from ref-OMA to CT-P39 at Week 12. Our results support the therapeutic equivalence of CT-P39 and ref-OMA in the treatment of patients with CSU."

Clinical • PK/PD data • Immunology • Inflammation

Biologic therapy for chronic spontaneous urticaria in pediatrics and adolescents: current landscape, challenges, and future perspectives. (PubMed, Expert Opin Biol Ther) - "Ligelizumab, a next-generation anti-IgE mAb, showed effectiveness in adults but lacks pediatric studies. CT-P39, a biosimilar to omalizumab, demonstrates promise, yet adolescent-specific outcomes are undisclosed. Dupilumab's recent approval for atopic dermatitis in children from 6 months onwards signifies progress...Despite challenges, the biology therapy outlook for pediatric and adolescent CSU is promising. Importantly, studies indicate that pediatric CSU is at least as prevalent as in adults, highlighting the need for approved treatments in this population."

Journal • Review • Asthma • Atopic Dermatitis • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Immunology • Pediatrics • Pulmonary Disease • Respiratory Diseases • Urticaria

Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe (Businesswire) - "Celltrion today announced that the European Commission (EC) has approved Omlyclo (CT-P39), an omalizumab biosimilar referencing Xolair. Omlyclo is approved for the treatment of allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP)....The decision is based on clinical evidence, including results from a global Phase III clinical trial designed to evaluate the efficacy..."

European regulatory • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria

Celltrion’s Xolair biosimilar CT-P39 gets approval recommendation in Europe (Korea Biomedical Review) - "Celltrion said Monday it has received a recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to grant the marketing authorization for the full-label application of CT-P39, a biosimilar to Xolair (omalizumab)....With the CHMP's recommendation, Celltrion expects final approval from the EC as early as May. If so, CT-P39 will be the first biosimilar of Xolair to be approved in Europe and become a 'first mover' product. Celltrion added that upon receipt of the approval, It plans to commercialize the product as soon as possible to enable rapid market entry."

European regulatory • Chronic Spontaneous Urticaria • Immunology • Urticaria

Celltrion USA completes submission of Biologics License Application (BLA) to U.S. FDA for CT-P39, an interchangeable biosimilar candidate of XOLAIR (omalizumab) (PRNewswire) - "Celltrion USA today announced that the company has submitted a Biologics License Application (BLA) for CT-P39, an interchangeable biosimilar candidate to XOLAIR (omalizumab) to the U.S. Food and Drug Administration (FDA)....The BLA submission includes results from a global Phase III clinical trial designed to evaluate the efficacy, safety, and pharmacokinetics of CT-P39 compared to the reference product XOLAIR in patients with chronic spontaneous urticaria (CSU) up to Week 40."

BLA • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Celltrion seeks approval for Xolair biosimilar in Canada (Korea Biomedical Review) - "Celltrion said Wednesday that it has completed the submission of its marketing authorization application for its Xolair (omalizumab) biosimilar, CT-P39, to Health Canada....The application is based on results from Celltrion's global phase 3 clinical trial of CT-P39, which enrolled a total of 619 patients with chronic spontaneous urticaria (CSU) in six EU countries, demonstrating the efficacy and equivalence of CT-P39 to the originator drug and confirmed similarity in safety. Based on these results, Celltrion completed a license application to Health Canada for all indications for which the original drug was licensed, including allergic asthma, chronic rhinosinusitis, and chronic urticaria."

Canadian regulatory • Asthma • Chronic Spontaneous Urticaria • Immunology • Respiratory Diseases • Urticaria

Celltrion proves biosimilar CT-P63’s bioequivalance to asthma treatment Xolair (Korea Biomedical Review) - P3 | N=619 | NCT04426890 | Sponsor: Celltrion | "Celltrion said it confirmed the bioequivalence of CT-P39, a biosimilar referencing Xolair (ingredient: omalizumab), compared to the original drug through a global phase 3 clinical trial....The company presented the results during the American College of Allergy, Asthma and Immunology (ACAAI) 2023, held in Anaheim, California from Thursday to Monday (local time)....CT-P39 and Xolair were administered to groups in dosages of 300mg and 150mg, and the change in the Weekly Itch Severity Score (ISS7) from baseline at week 12 was measured as the primary endpoint. As a result, CT-P39 met the predefined equivalence criteria and showed similar results in secondary endpoints such as safety and immunogenicity compared to Xolair."

P3 data • Chronic Spontaneous Urticaria • Immunology • Urticaria

Efficacy and Safety of CT-P39 compared to Reference Omalizumab in Patients with Chronic Spontaneous Urticaria (ACAAI 2023) - "Conclusion The therapeutic equivalence of CT-P39 to ref-omalizumab was demonstrated as evaluated in mean changes from baseline of ISS7 at Week 12. CT-P39 was well tolerated with a safety profile comparable to that of ref-omalizumab."

Clinical • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria