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

Celltrion Secures Canadian Approval for ‘Steqeyma’ Autoinjector Formulation (Korea Medicare) - "This regulatory milestone secures two specific AI strengths for the Canadian market: 45 mg/0.5 mL and 90 mg/1.0 mL....Celltrion intends to use this Canadian approval as a springboard to accelerate its broader North American strategy."

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

Celltrion biosimilars gain share in Australia and New Zealand (Korea Biomedical Review) - "According to IQVIA, as of the third quarter of 2025, the biosimilar Herzuma (trastuzumab), used to treat breast and gastric cancers, held more than 56 percent of the market in Australia....In autoimmune disease treatments, Celltrion’s Remsima (infliximab) and Remsima SC (subcutaneous formulation) hold a combined market share of 58 percent in Australia....Steqeyma (ustekinumab) reached a 12 percent market share within its first quarter of sales, based on IQVIA data."

Commercial • Ankylosing Spondylitis • Crohn's disease • Gastric Cancer • HER2 Positive Breast Cancer • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Celltrion's 52-Week STEQEYMA Clinical Trial Results Published in International Dermatology Journal (The Asia Business Daily) - "This study presents 52-week, long-term clinical data from a global Phase 3 trial involving 509 patients with moderate to severe plaque psoriasis....The clinical results showed that the efficacy between the STEQEYMA group and the original drug group was comparable. Among patients who switched from the original drug to STEQEYMA, efficacy was stably maintained compared to those who continued on the original drug. In terms of safety, there were no significant differences in adverse events among any of the groups."

P3 data • Psoriasis

A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=162 | Completed | Sponsor: Celltrion | Trial completion date: Apr 2026 ➔ Dec 2025 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date

Comparative Efficacy and Safety of Advanced Therapies in Maintenance Treatment of Adult Patients with Moderate-to-Severe Crohn's Disease: A Systematic Literature Review and Network Meta-Analysis. (PubMed, Adv Ther) - "The current NMA integrating recently updated phase 3 data in CD indicated that no single treatment significantly outperformed others in achieving clinical remission and endoscopic response, although SC infliximab 120 mg q.2.w exhibited highest numerical efficacy as both a first-line and second-or-later-line maintenance treatment in adult patients with moderate-to-severe CD."

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

Celltrion said on the 31st that, on a consolidation basis, fourth-quarter sales are tentatively tallied at 1.2839 trillion won, up 20.7% from a year earlier, and operating profit at 472.2 billion won, up 140.4% from a year earlier (Chosun Biz) - "Celltrion said the result was driven by steady growth in existing flagship products and the rapid sales traction of high-margin new products that have settled into the global market. According to the company, new products such as the autoimmune disease treatment Remsima SC (U.S. product name Zymfentra), Yuflyma, the anticancer drug Vegzelma, and Steqeyma posted double-digit growth in the fourth quarter."

Sales • Ankylosing Spondylitis • Colorectal Cancer • Crohn's disease • Hidradenitis Suppurativa • Idiopathic Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

Celltrion receives positive CHMP Opinion for SteQeyma (ustekinumab biosimilar) autoinjector (Businesswire) - "The positive CHMP opinion is for SteQeyma autoinjector in 45mg/0.5mL and 90mg/1mL, expanding the currently approved SteQeyma presentation, which includes 45mg/0.5mL, 90mg/1mL in a pre-filled syringe and 45mg/0.5mL in a vial for subcutaneous injection, as well as 130mg/26mL concentrate for solution for intravenous infusion."

CHMP • Crohn's disease • Psoriasis • Psoriatic Arthritis

Celltrion said Wednesday that New Zealand's drug regulator, Medsafe, has approved Steqeyma (CT-P43), its biosimilar to Janssen's immune-suppressing medicine Stelara (ustekinumab). (Korea Biomedical Review) - "The clearance covers all of Stelara's approved uses in New Zealand -- plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis -- and allows sales in both vials and prefilled syringes."

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

…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 to sell autoimmune drug Stelara biosimilar at Costco in US (KED Global) - "Celltrion inked a listing agreement for Steqeyma with Costco Health Solutions, the retailer’s pharmacy benefit manager (PBM)."

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

A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=162 | Active, not recruiting | Sponsor: Celltrion | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

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

Celltrion expands footprint in Italy with continued wins for autoimmune…drugs (Korea Biomedical Review) - "Celltrion’s Italian subsidiary recently won additional tenders for its ustekinumab biosimilar, Steqeyma, in the Veneto, Trentino-Alto Adige, and Sardinia regions, following earlier contracts in four regions this year...The company will supply the drug to seven regions in total through May 2026...Remsima IV won a recent tender in Umbria, while Remsima SC renewed its contract in Puglia, extending supply through May 2027...Celltrion’s adalimumab biosimilar Yuflyma is also gaining traction, with sales underway in Lazio and Umbria under contracts that will run for the next two to three years."

Commercial • Ankylosing Spondylitis • Crohn's disease • Hidradenitis Suppurativa • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Celltrion's operating profit hits record high in Q2 on strong sales of new high-margin drugs (Korea Biomedical Review) - "The company said its second quarter revenue reached 961.5 billion won ($690.5 million), up 9.9 percent year-on-year, while operating profit jumped 234.5 percent to 242.5 billion won -- both all-time highs for the second quarter...The strong performance was driven by robust demand for Remsima SC (marketed as Zymfentra in the U.S.), a subcutaneous infliximab biosimilar for autoimmune diseases, Yuflyma, an adalimumab biosimilar for rheumatoid arthritis and inflammatory conditions, Vegzelma, a bevacizumab biosimilar used in cancer treatment, and Steqeyma, a ustekinumab biosimilar targeting psoriasis and Crohn’s disease."

Commercial • Breast Cancer • Crohn's disease • Glioblastoma • Immunology • Inflammatory Bowel Disease • Non Small Cell Lung Cancer • Ovarian Cancer • Psoriasis • Rheumatoid Arthritis

Bringing IBD treatment options to the table. The latest developments in the Celltrion Healthcare IBD portfolio. (BSG 2025) - "Adverse events should also be reported to Celltrion Healthcare by emailing UKadverseevents@celltrionhc.com or calling +44 (0) 1753 983 500 For full indications, contraindications and information on special warnings, precautions and adverse events, please refer to the Summary of Product Characteristics. Please click here to view the Remsima® (infliximab) IV prescribing information: Please click here to view the Remsima® (infliximab) SC prescribing information: Please click here to view the Yuflyma®▼(adalimumab) prescribing information: Please click here to view the SteQeyma® (ustekinumab) prescribing information: UK--25-00086 May 2025"

Gastroenterology • Inflammatory Bowel Disease

Introducing the Celltrion IBD portfolio including SteQeyma®▼(ustekinumab) and Remsima® (infliximab) SC data (BSG 2025) - "Sponsored by Celltrion Healthcare UK Ltd"

Inflammatory Bowel Disease

Celltrion Secures Health Canada Approval for Pediatric Formulation of STEQEYMA (Korea IT Times) - "Celltrion announced on June 16 that it has received additional regulatory approval from...Health Canada for a new formulation of its biosimilar for autoimmune diseases, STEQEYMA (development code: CT-P43). The newly approved formulation is a 45mg/0.5mL vial, primarily intended for treating pediatric patients."

Canada approval • Psoriasis

Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA (ustekinumab-stba), expanding dosing options for pediatric patients (PRNewswire) - "Celltrion...announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA). With this approval, STEQEYMA now offers all dosage forms and strengths of its reference product, providing flexibility to meet physicians' clinical needs while supporting treatment continuity for patients....The FDA 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."

FDA approval • Psoriasis • Psoriatic Arthritis

Celltrion secures European approval for Stellara biosimilar Qoyvolma (Chosun Biz) - "Celltrion announced on the 9th that its autoimmune disease treatment drug Stelara (STELARA; ingredient name ustekinumab) biosimilar Qoyvolma has received product approval from the European Commission (EC). Qoyvolma has received approval by adding ulcerative colitis (UC) to the existing approved Stelara biosimilar Steqeyma's treatment indications..."

EMA approval • Ulcerative Colitis

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

New trial • Crohn's disease • Dermatology • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Psoriasis

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

Celltrion's Steqeyma gains wider insurance coverage in US (The Korea Herald) - "South Korean biopharmaceutical firm Celltrion announced Thursday that it has signed a second major deal with one of the top five pharmacy benefit managers in the US, securing private insurance coverage for its autoimmune disease treatment, Steqeyma (ustekinumab). Starting July 1, Steqeyma will be eligible for reimbursement through the newly secured PBM, significantly broadening patient access....According to pharmaceutical market research firm IQVIA, the global market for ustekinumab reached $21.6 billion in 2024, with the US accounting for nearly 77 percent."

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

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