Steqeyma (ustekinumab-stba) / Celltrion, Hikma - LARVOL DELTA

Mirikizumab (Omvoh) - an IL-23 antagonist for Crohn's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IL23A

A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=160 | Not yet recruiting | Sponsor: Celltrion

New P1 trial

Celltrion secures bids for three autoimmune disease biosimilars in Italy [Google translation] (Chosun Biz) - "First, the Steqeyma biosimilar of Ustekinumab...has recently been awarded contracts in the Ustekinumab bids held by the governments of four regions in Italy, including Piedmont, Aosta Valley, Liguria, and Sardinia. Steqeyma is expected to be supplied to these areas until 2028...The YUFLYMA biosimilar of Adalimumab, for the treatment of rheumatoid arthritis and psoriasis from AbbVie, has also been successful in bidding. It was awarded in the Adalimumab bids held in regions including Lazio, Lombardy, and Umbria. Starting this month, YUFLYMA will be supplied to Lazio and Lombardy for the next three years and to Umbria for two years....The REMSIMA biosimilar of Infliximab from J&J has recently been awarded in the Umbria bids and is expected to be supplied for two years until 2027. The subcutaneous injection (SC) product of REMSIMA, REMSIMA SC, has also created a new market in the Sardinia state government, where there has been no bidding market for the Infliximab SC..."

Commercial • Ankylosing Spondylitis • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis

Celltrion's STEQEYMA (ustekinumab-stba), now added to the Costco Member Prescription Program (PRNewswire) - "Celltrion, Inc., today announced that STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab) has been added to the Costco Member Prescription Program...STEQEYMA is available in both subcutaneous injection and intravenous infusion and is indicated for the treatment of plaque psoriasis (PsO) and psoriatic arthritis (PsA) in adult and pediatric patients, as well as Crohn's disease (CD) and ulcerative colitis (UC) in adult patients...The Costco Member Prescription Program is a prescription drug discount card program offered by Costco Health Solutions that provides eligible Costco members and their eligible dependents the ability to obtain lower prices on STEQEYMA and other participating drugs at Costco Specialty Pharmacies and at participating pharmacies....STEQEYMA will be available in the U.S. from Costco Specialty Pharmacies on April 1st, 2025, for self-funded employer plans and Costco members who are uninsured and want to pay cash for their STEQEYMA..."

Reimbursement • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 March 2025 (European Medicines Agency) - "On 27 March 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Qoyvolma, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis, Crohn’s disease or ulcerative colitis....Qoyvolma will be available as a 45 or 90 mg solution for injection in pre-filled syringes, and a 130 mg concentrate for solution for infusion. The active substance of Qoyvolma is ustekinumab, an immunosuppressant interleukin inhibitor (ATC code: L04AC05)."

CHMP • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), now available in the United States (PRNewswire) - "Celltrion today announced the U.S. launch of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), following approval by the U.S. Food and Drug Administration (FDA) in December 2024....STEQEYMA is indicated for the treatment of plaque psoriasis (PsO) and psoriatic arthritis (PsA) in adult and pediatric patients, as well as Crohn's disease (CD) and ulcerative colitis (UC) in adult patients. It is available in both subcutaneous injection and intravenous infusion....STEQEYMA will be priced with a WAC list price at an 85% discount to the current WAC list price of STELARA to help improve patient access to high-quality biologic treatments."

Biosimilar launch • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Guselkumab (Tremfya) for ulcerative colitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Celltrion's 'Steqeyma' launched in 5 major European countries including Germany [Google translation] (HIT News) - "Celltrion...announced on the 23rd that it will launch its autoimmune disease treatment drug 'Steqeyma' in five major European countries (Germany, the UK, France, Italy, and Spain) and begin its full-scale market conquest...Steqeyma was launched in France on the 20th, and the company explained that it is intensifying promotional activities targeting patients with inflammatory bowel disease and specialists...In addition, it announced plans to start observational clinical trials next month and to carry out customized marketing that reflects the needs of medical professionals....The company said that Steqeyma will be launched in Italy and Spain in the middle of this month..."

Biosimilar launch • New trial • Crohn's disease • Inflammatory Bowel Disease • Psoriatic Arthritis • Ulcerative Colitis

Network Meta-analysis to Evaluate the Comparative Efficacy of Advanced Therapies as First-Line Treatment for Maintenance Treatment of Adult Patients With Moderate to Severe Crohn's Disease (AIBD 2024) - "Background: Subcutaneous (SC) CT-P13 provides patients and physicians with a new opportunity for maintenance treatment of Crohn's disease (CD)... Eligible studies, identified by systematic literature review (PROSPERO no: CRD42023413752), evaluated the efficacy of maintenance therapy using intravenous (IV) or SC infliximab, SC adalimumab, IV or SC vedolizumab, SC ustekinumab, SC risankizumab or oral upadacitinib, in patients with moderate to severe CD who responded to induction therapy... In this updated NMA, SC infliximab 120 mg Q2W demonstrated a favorable profile in achieving clinical remission and endoscopic response when administered as a first-line advanced therapy for maintenance treatment of patients with moderate to severe CD."

Metastases • Retrospective data • Crohn's disease • Immunology • Inflammatory Bowel Disease

U.S. FDA approves Celltrion’s STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab) (PRNewswire) - "STEQEYMA is expected to be marketed in the U.S. in February 2025...Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis."

FDA approval • Launch US • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Celltrion releases Stelara biosimilar in Germany, Netherlands (Korea Biomedical Review) - "Celltrion said Monday that it has launched Steqeyma (ingredient: ustekinumab), its biosimilar to Stelara, in Germany, aiming to enhance its leadership in the biopharmaceutical sector by expanding its product portfolio for autoimmune disease treatment....In Finland, a key market in Northern Europe, Steqeyma is slated for release in mid-November...Additionally, Celltrion plans to launch Steqeyma in Ireland later this month."

Biosimilar launch • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

Would ustekinumab biosimilars bring positive changes to patient access to PsO and PsA treatment in Sweden? (EADV 2024) - "Ustekinumab reimbursement is currently limited due to the high cost of treatment. However, once the biosimilar is launched in Sweden, patient access to ustekinumab is expected to improve dramatically. In addition to budget savings, patients will benefit from the long-acting agent, which requires only 4 injections in a year."

Clinical • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • IL23A

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 Stelara biosimilar secures UK approval (Korea Biomedical Review) - "Celltrion said its Stelara (ingredient: ustekinumab) biosimilar, Steqeyma, received marketing authorization from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). Steqeyma is set to treat various inflammatory diseases including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis."

MHRA approval • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

European Commission approves Celltrion’s SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for the treatment of multiple chronic inflammatory diseases (Businesswire) - "Celltrion today announced that the European Commission (EC) has approved the use of SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases. SteQeyma is approved as a biologic therapy in gastroenterology, dermatology and rheumatology indications....The decision from the EC follows a positive opinion recommending SteQeyma from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2024....The EC approval of SteQeyma was based on the totality of evidence, including the results from a Phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms."

EMA approval • Crohn's disease • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Celltrion receives approval for Stelara biosimilar in Canada (Korea Biomedical Review) - "Celltrion said it has received New Drug Submission (NDS) approval from Health Canada for its biosimilar Steqeyma. Steqeyma, a biosimilar referencing Janssen's Stelara (ingredient: ustekinumab), is set to treat various inflammatory diseases including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis."

Canada approval • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024 (European Medicines Agency) - "The committee recommended granting a marketing authorisation for Steqeyma (ustekinumab), a biosimilar medicine for the treatment of adult patients with moderately-to severely-active Crohn’s disease, plaque psoriasis, paediatric plaque psoriasis and psoriatic arthritis."

CHMP • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis

Celltrion's Stelara biosimilar receives approval in Korea (The Korea Herald) - "South Korean biosimilar giant Celltrion announced Thursday that Steqeyma, the company’s biosimilar referencing Stelara, has been approved by the Ministry of Food and Drug Safety...Celltrion said Steqeyma has been approved for its uses in all indications of reference product Stelara, including psoriatic arthritis, Crohn's disease and ulcerative colitis...Celltrion is now able to sell Steqeyma in the Korean market. But, when the drug will be launched domestically is not yet decided, according to the company...Celltrion is currently seeking US and European approvals for Steqeyma. Celltrion submitted its applications....to the US Food and Drug Administration in the following month."

FDA filing • Korea approval • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

NETWORK META-ANALYSIS TO EVALUATE THE COMPARATIVE EFFICACY OF ADVANCED THERAPIES AS FIRST LINE FOR MAINTENANCE TREATMENT OF ADULT PATIENTS WITH MODERATE-TO-SEVERE CROHN’S DISEASE (DDW 2024) - "Background Subcutaneous (SC) CT-P13 provides patients and physicians with a new opportunity for maintenance treatment of Crohn's disease (CD)...: CRD4 0 341375 ) evaluated the efficacy of maintenance therapy using intravenous (IV) or SC infliximab SC adalimumab IV or SC vedolizumab SC ustekinumab SC risankizumab or oral upadacitinib in patients with moderate-to-severe CD who responded to induction therapy...Barberio B et al . Gut 0 3;7 : 64-74."

Metastases • Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Oncology

Budget Impact of Infliximab Subcutaneous from the US Healthcare Perspective (ISPOR 2024) - "The model assumed to compare costs of the following molecules: certolizumab, golimumab, vedolizumab, ustekinumab, upadacitinib, risankizumab, tofacitinib, and natalizumab. The base case of this BIM takes into account how infliximab SC will impact IBD treatment budget from a US perspective. Infliximab is considered as a potent treatment compared to the recently developed biologics. The model, based on the assumption that analyzed molecules have similar efficacy, suggests that treatment with Zymfentra will yield cost savings while improving patient convenience and offering intangible benefits."

HEOR • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Network meta-analysis to evaluate the comparative efficacy of advanced therapies as first line for maintenance treatment of adult patients with moderate-to-severe Crohn’s disease (ECCO-IBD 2024) - "Background Subcutaneous (SC) CT-P13 provides patients and physicians with a new opportunity for maintenance treatment of Crohn’s disease (CD)...Methods Eligible studies, identified by systematic literature review (PROSPERO no.: CRD42023413752), evaluated the efficacy of maintenance therapy using intravenous (IV) or SC infliximab, SC adalimumab, IV or SC vedolizumab, SC ustekinumab, SC risankizumab or oral upadacitinib, in patients with moderate-to-severe CD who responded to induction therapy...2 Barberio B et al . Gut 2023;72:264–74."

Metastases • Retrospective data • Crohn's disease • Immunology • Inflammatory Bowel Disease

CT-P43 Shows Equivalent Efficacy, Safety for Plaque Psoriasis vs Ustekinumab (HCPLive) - '"This study demonstrated the equivalence in terms of efficacy of CT-P43 and originator ustekinumab in patients with moderate to severe plaque psoriasis. The [pharmacokinetic], safety and immunogenicity profiles of CT-P43 and originator ustekinumab were comparable,' investigators added."

Media quote • Psoriasis

Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study. (PubMed, BioDrugs) - P3 | "CT-P43 demonstrated equivalent efficacy to originator ustekinumab in patients with moderate to severe plaque psoriasis, with comparable pharmacokinetic, safety and immunogenicity profiles."

Journal • P3 data • Dermatology • Immunology • Psoriasis

Network Meta-Analysis to Evaluate the Comparative Efficacy of Biologics for Maintenance Treatment of Adult Patients With Crohn’s Disease (ACG 2023) - "CT-P13 subcutaneous (SC) provides patients with a new opportunity for maintenance treatment of their disease...Among 8 comparator arms, infliximab (IFX) SC 120 mg every 2 weeks (Q2W) showed the highest odds ratio (95% confidence interval [CI]) vs. PBO (3.52 [2.18–5.65]), followed by adalimumab (ADL) SC 40 mg Q2W (2.92 [1.90–4.47]), ustekinumab (UST) SC 90 mg every 8 weeks (Q8W) (2.79 [1.85–4.21]), IFX IV 5 mg/kg Q8W (2.55 [1.29–5.27]), vedolizumab (VDZ) IV 300 mg Q8W (2.33 [1.43–3.86]), risankizumab (RZB) SC 180 mg Q8W (1.80 [1.15–2.84]), VDZ SC 108 mg Q2W (1.76 [1.14–2.70]), and RZB SC 360 mg Q8W (1.60 [1.00–2.52])... Overall, 8 RCTs were included in the analysis (ACCENT I, LIBERTY-CD, CHARM, SEAVUE, GEMINI 2, VISIBLE 2, IM-UNITI, FORTIFY). Most studies enrolled both naïve and biologic- and/or Janus kinase inhibitor-exposed patients, apart from ACCENT-1 and SEAVUE which enrolled only anti-tumour necrosis factor- and biologic-naïve patients, respectively. The..."

Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Oncology

Celltrion announces global phase 3 clinical trial results for ‘CT-P43’ at the European Dermatology Conference [Google translation] (HIT News) - P3 | N=509 | NCT04673786 | Sponsor: Celltrion | "Celltrion...announced on the 11th (local time) at the European Academy of Dermatology and Venereology (EADV) its biosimilar to ‘STELARA’, ‘CT-P43’...announced the results of the global phase 3 clinical trial of ‘Kinumab’....At this conference, Celltrion unveiled the results of a global phase 3 clinical trial conducted on 509 patients with plaque psoriasis through a poster....For the Stelara treatment group, the results were analyzed from the 16th week of administration until the 52nd week after switching to CT-P43 or maintaining Stelara treatment. According to the company, similarities in efficacy and safety were confirmed between the Stelara administration group and the CT-P43 administration group. In the results of monitoring up to 52 weeks after switching from Stelara to CT-P43, the efficacy remained similar to that of the Stelara treatment maintenance group."

P3 data • Immunology • Psoriasis