Imuldosa (ustekinumab-srlf) / Dong-A, Intas, Meiji Seika - LARVOL DELTA

Pharmacokinetics, Safety, and Immunogenicity of DMB-3115, a Ustekinumab Biosimilar for Immune-Mediated Diseases, in Healthy Japanese Male Participants: A Randomized, Double-Blind, Single-Dose Study. (PubMed, Adv Ther) - "Bioavailability of DMB-3115 was considered similar to that of Stelara in the Japanese population. DMB-3115 was well tolerated without any new safety concern."

Clinical • Journal • PK/PD data

Association Between Efficacy and Pharmacokinetics of DMB-3115 and its Originator Ustekinumab in Patients with Chronic Plaque Psoriasis: An Exposure-Response Analysis. (PubMed, Adv Ther) - "The difference in Cmax of DMB-3115 is not expected to have a meaningful impact on its efficacy."

Journal • PK/PD data • Dermatology • Immunology • Psoriasis

Beyond Similarity: Clinical and Real-World Insights into Ustekinumab Biosimilars (AOCC-IMKASID 2026) - No abstract available

Clinical • Real-world • Real-world evidence

Accord BioPharma's IMULDOSA (ustekinumab-srlf) Now Preferred Under Cigna Healthcare Commercial Plans (PRNewswire) - "Effective April 15, 2026, coverage includes: IMULDOSA prefilled syringes — Preferred on all Cigna Healthcare commercial pharmacy benefit drug lists; IMULDOSA vials — Preferred on the Cigna Healthcare commercial medical benefit."

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

Dong-A ST announced on Wednesday that Health Canada has granted marketing authorization for Imuldosa (ingredient: ustekinumab), a biosimilar to Janssen’s blockbuster drug Stelara. (Korea Biomedical Review)

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

A randomized, double-blind, phase 3 study to compare efficacy, safety, and immunogenicity between DMB-3115 and reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. (PubMed, JAAD Int) - "Data were only through week 52. DMB-3115 showed a similar clinical efficacy and safety profile to ustekinumab in patients with moderate-to-severe plaque psoriasis."

Clinical • Journal • P3 data • Dermatology • Immunology • Psoriasis

Accord BioPharma Inc...has added IMULDOSA (ustekinumab-srlf) to its largest commercial formularies, including National Preferred Formulary, effective September 5, 2025. (PRNewswire)

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

Peek Healthcare Technologies, Inc. ('Peek') Launches Direct-to-Employer and Direct-to-Patient Pricing for IMULDOSA (ustekinumab-srlf) (Stelara Biosimilar) (ACCESS Newswire) - "Effective immediately, IMULDOSA will be available through the Peek Meds Marketplace."

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

Korea’s Dong-A ST has launched its Stelara (ustekinumab) biosimilar Imuldosa in the United States through partners Intas Pharmaceuticals and Accord Biopharma... (Korea Biomedical Review)

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

Pharmacokinetic Bioequivalence, Safety, and Immunogenicity of DMB-3115, an Ustekinumab Biosimilar, and EU- and US-Stelara in Healthy Adult Participants: A Randomized, Double-Blind, Single-Dose Study. (PubMed, Adv Ther) - "DMB-3115 was bioequivalent to both reference ustekinumab in terms of pharmacokinetic profile and showed similar safety and immunogenicity profile after a single subcutaneous injection in parallel groups of healthy adult participants."

Clinical • Journal • PK/PD data • Back Pain • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Musculoskeletal Pain • Pain • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis

Dong-A ST sees profit inch down amid rising R&D costs, readies US biosimilar launch (Korea Biomedical Review) - "Prescription drug sales rose 4.8 percent to 443.5 billion won, driven by a 20.5 percent surge in sales of Growtropin, Korea’s first locally developed growth hormone therapy, which brought in 118.9 billion won....Meanwhile, overseas sales jumped 8.3 percent to 151.1 billion won, fueled by higher demand for Bacchus energy drink and sales from IMULDOSA (ustekinumab), a Stelara biosimilar, which contributed 7.5 billion won."

Sales • Crohn's disease • Growth Hormone Deficiency (Pediatric) • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Accord Healthcare is granted marketing authorisation for IMULDOSA, ustekinumab biosimilar to Stelara (PRNewswire) - "Accord announces that the European Commission (EC) has granted marketing authorisation for Imuldosa (development code: DMB-3115), a biosimilar to Stelara...The EC approval follows a positive opinion issued on 19 October 2024 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...The CHMP positive opinion is based on a comprehensive package of analytical, non-clinical, and clinical similarity data, including a multi-regional phase III clinical trial in patients with plaque psoriasis. The study confirmed therapeutic equivalence, in the primary outcome, between DMB-3115 and Stelara, alongside a comparable safety profile."

EMA approval • Immunology • Psoriasis

Dong-A ST-Dong-A Socio Holdings CEO Exchange Successful… Attention to the 4th Quarter (Google translation) (Medipana) - "The increase in overseas sales of DMB-3115 (US product name Imuldosa) will lead to the expansion of sales of Estigene Bio, a subsidiary of Dong-A Socio Holdings. As of the first half of this year, Dong-A Socio Holdings owns an 80.4% stake in Estigene Bio."

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

Optimal timeframe for achieving biochemical remission in Crohn's disease patients treated with first-line biologics: A retrospective multicenter study. (PubMed, Medicine (Baltimore)) - "The duration and value difference for CRP normalization between anti-tumor necrosis factor agents, ustekinumab, and vedolizumab were statistically insignificant...Treatment with 5-aminosalicylic acid (HR 2.77; 95% confidence interval [CI] 1.26-6.11) and high albumin level (HR 1.64, 95% CI 1.04-2.61) favored early CRP normalization, whereas structuring behavior less likely than inflammatory behavior (HR 0.43, 95% CI 0.19-0.96). We have provided the actual rate of achieving CRP normalization and its appropriate timeframe as an initial target in CD treatment."

Clinical • Journal • Observational data • Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Oncology • CRP • TNFA

Efficacy of Second-Line Biological Therapies in Moderate to Severe Ulcerative Colitis Patients with Prior Failure of Anti-Tumor Necrosis Factor Therapy: A Multi-Center Study. (PubMed, J Pers Med) - "Based on real-world data, second-line biological therapy with ustekinumab, vedolizumab, and tofacitinib showed comparable efficacy in patients with moderate to severe UC with prior exposure to anti-TNF therapy."

Journal • Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Herpes Zoster • Hypertriglyceridemia • Immunology • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • Varicella Zoster

Accord Healthcare receives positive CHMP opinion for IMULDOSA, a ustekinumab biosimilar to Stelara (PRNewswire) - "Accord Healthcare Limited (Accord) a subsidiary of Intas Pharmaceuticals, announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for Imuldosa (development code: DMB-3115), a biosimilar of Stelara (ustekinumab), marketed by Janssen Biotech Inc., a subsidiary of Johnson & Johnson."

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

Dong-A ST Receives FDA Approval for Stelara Biosimilar 'IMULDOSA' (Korea IT Times) - "Dong-A ST announced...that its biosimilar to Stelara, named 'IMULDOSA' (project name DMB-3115, active ingredient ustekinumab), has received product approval from the U.S. Food and Drug Administration (FDA). Accord Biopharma, a subsidiary of Dong-A ST’s partner Intas, submitted the Biologics License Application (BLA) for FDA approval in October 2023, and it was approved on October 10 (U.S. local time)."

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

Comparative real-world outcomes between ustekinumab, infliximab, and adalimumab in bio-naïve and bio-experienced Crohn's disease patients: a retrospective multicenter study. (PubMed, BMC Gastroenterol) - "This study suggests that UST, IFX, and ADA are equally effective in bio-naïve CD patients, while in bio-experienced patients, mostly with previous exposure to anti-TNF agents, UST may offer superior drug durability."

Clinical • Journal • Real-world • Real-world evidence • Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Oncology

One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn's Disease: The K-STAR Study. (PubMed, Inflamm Bowel Dis) - P=N/A | "Ustekinumab was well-tolerated, effective, and safe as induction and maintenance therapy for CD in Korea."

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

ONE-YEAR SAFETY AND EFFECTIVENESS OF USTEKINUMAB IN PATEITNS WITH CROHN'S DISEASE: THE K-STAR STUDY (DDW 2024) - P=N/A | "ConclusionUST was well-tolerated effective and safe as induction and maintenance therapy for patients with CD in Korea. The results from this study enhance our understanding of the role of UST in managing CD patients with diverse characteristics and may help inform clinical decisions."

Clinical • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • CRP

Comparative Real -world Outcomes between Ustekinumab, Infliximab, and Adalimumab in Bio -nave and Bio -experienced Crohn's Disease Patients: A Retrospective Multicenter Study (IMKASID 2024) - "In bio-experienced CD patients, with 35 in the UST group and 13 in the anti-TNF agents group, the UST group showed a lower risk of drug discontinuation (P = 0.004) than the anti-TNF agents group. Conclusion : This study suggests that UST, IFX, and ADA are equally effective in bio-naïve CD patients, while in bio-experienced patients, mostly with previous exposure to anti-TNF agents, UST may offer superior drug durability."

Real-world • Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

One-year safety and effectiveness of ustekinumab in patients with Crohn’s disease: The K-STAR study (ECCO-IBD 2024) - P=N/A | "Conclusion UST was well-tolerated, effective, and safe as induction and maintenance therapy for patients with CD in Korea. The results from this study enhance our understanding of the role of UST in managing CD patients with diverse characteristics and may help inform clinical decisions."

Clinical • Crohn's disease • Immunology • Inflammatory Bowel Disease • CRP

FDA Accepts for Review BLA for DMB-3115 of Dong-A ST, a Proposed Biosimilar to Stelara (Ustekinumab) (Businesswire) - "Dong-A ST...announced that Accord BioPharma, Inc., a subsidiary of Intas Pharmaceuticals Ltd, in the United States has received a notification that the US Food and Drug Administration ('FDA') has accepted its Biologics License Application (BLA) for DMB-3115, a proposed biosimilar to Stelara (Ustekinumab), for substantive review....The BLA leverages the analytical similarity assessment data between EU and US sourced Stelara® and DMB-3115. A global clinical Phase III trial was performed on patients with moderate-to-severe chronic plaque psoriasis."

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

Accord BioPharma, Inc. Announces U.S. FDA Acceptance of Biologics License Application for Proposed STELARA Biosimilar DMB-3115 (PRNewswire) - "Accord BioPharma, Inc. the U.S. specialty division of Intas Pharmaceuticals Ltd...announced today the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115. DMB-3115 is a proposed biosimilar to STELARA^®, a blockbuster drug developed by Janssen Biotech, Inc. and approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis....The BLA submission for DMB-3115 is based on results from phase III multi-regional clinical trials in patients with plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms."

BLA • Immunology • Inflammation • Psoriasis

“Dong-A ST approves Stelara similar in the second half of next year and announces phase 1 results for NASH and obesity treatment” [Google translation] (Insight Korea) - "'In addition, there is a lot of momentum in the second half of 2024, with the approval of Stelara biosimilar DA-3115, announcement of phase 1 results for NASH treatment DA-1241, and phase 1 interim results for obesity treatment DA-1726. Once the obesity treatment DA-1726 completes Phase 1a in the first half of next year, it is expected to enter Phase 1b/2a and confirm efficacy in 20’5 before technology transfer...'"

BLA • New P1/2 trial • P1 data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Obesity • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis