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

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

European Medicine Agency accepts Intas' Marketing Authorization Application for DMB-3115, a Proposed Biosimilar to Stelara (Ustekinumab) (PRNewswire) - "Intas Pharmaceuticals Ltd. announced that the European Medicine Agency (EMA) confirms acceptance of the Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab). The MAA has been submitted by Accord Healthcare, a wholly owned subsidiary of Intas Pharmaceuticals Ltd. on June 23rd, and the EMA accepted the MAA submission on 14th July....The MAA submission is based on results from the phase III multi-regional clinical trials in patients with plaque psoriasis (NCT04785326)."

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

Dong-A ST "Apply for U.S. approval for the third quarter of Stellara similar" [Google translation] (Daily Pharm) - "Dong-A ST plans to apply for US approval for its 'Stelara' biosimilar in the third quarter. European permission will be attempted during this month. Dong-A ST plans to apply for European permission for DMB-3115 during the first half of the year. This means that it will submit an approval application to the European Medicines Agency (EMA) within this month. It plans to apply for approval to the US Food and Drug Administration (FDA) in the third quarter. Initially, the FDA approval application was scheduled to proceed within the first half of the year. However, due to the time required to prepare documents, the schedule was delayed."

BLA • European regulatory • Crohn's disease • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Ulcerative Colitis

"Dong-A ST Demonstrates Therapeutic Equivalence Between DMB-3115 and Stelara in Global Phase III https://t.co/fCswGejuJo" (@NewsFromBW)

Clinical

Dong-A ST’s Stelara biosimilar shows equivalence in global phase 3 study (Korea Biomedical Review) - P3 | N=605 | NCT04785326 | Sponsor: Dong-A ST Co., Ltd. | "Dong-A ST said on Monday that it confirmed the therapeutic equivalence and safety of its Stelara biosimilar DMB-3115 compared to the original drug in the global phase 3 clinical trials....The phase 3 clinical trials began in the U.S. in 2021 and subsequently launched in nine other countries, including Poland, Estonia, and Latvia. The efficacy, safety, and immunogenicity of DMB-3115 and Stelara subcutaneous injections were compared in 605 patients with moderate to severe chronic plaque psoriasis over 52 weeks. Dong-A ST’s candidate demonstrated therapeutic equivalence with Stelara via the psoriasis area and severity index (PASI) percentage change from baseline, the primary outcome measure, with no significant adverse effects at 8 and 12 weeks per the EMA and FDA standards."

P3 data • Immunology • Psoriasis

Opportuniti: Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3 | N=605 | Completed | Sponsor: Dong-A ST Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Dong-A ST completes global P3 study on Stelara biosimilar (Korea Biomedical Review) - "Dong-A ST said it has completed the global phase 3 clinical trial of DMB-3115, a biosimilar referencing Janssen’s plaque psoriasis treatment Stelara (ingredient: ustekinumab)....In the study, the company compared the efficacy, safety, and immunogenicity of DMB-3115 and Stelara subcutaneous injection in patients with moderate to severe chronic plaque psoriasis..."

Trial completion • Immunology • Psoriasis

Stellara’s US material patent expires from 2023…Where biosimilar phase 3 clinical trials are in progress [Google translation] (MedigateNews) - "As the patent expiry date of Johnson & Johnson (J&J)'s blockbuster autoimmune disease treatment Stelara (ingredient name: ustekinumab) approaches, the news of product development by biosimilar companies is being updated....Stellara's material patent expires in September 2023 in the United States and July 2024 in Europe....Dong-A ST is also spurring global clinical trials of DMB-3115 with Stelara [SIC] biosimilar....The clinical trial is expected to end in the second half of this year."

Patent • Trial completion date • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Opportuniti: Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3; N=590; Active, not recruiting; Sponsor: Dong-A ST Co., Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Dermatology • Immunology • Psoriasis

Dong-A ST, Meiji Seika Pharma license out DMB-3115 to Intas Pharma (Korea Biomedical Review) - "Dong-A ST and its Japanese partner Meiji Seika Pharma signed a global license-out agreement with Intas Pharmaceuticals for DMB-3115, a biosimilar of the inflammatory disease treatment Stelara...Dong-A ST and Meiji Seika Pharma will research and develop the biosimilar and have the right to the exclusive supply of finished products while transferring the monopolized rights concerning its approval and marketing in the world except for Korea, Japan, and some Asian countries to the multinational company."

Licensing / partnership • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Dong-A ST, 'Stellara Similar' Europe 1st Prize "Confirmation of equality" [Google translation] (Biospectator) - P1, N=296; "Dong-A ST announced...that it has recently completed the European phase 1 clinical trial of 'DMB-3115', a biosimilar of Stellara...administered subcutaneously to 296 healthy adults in the European Phase 1 clinical trial that was completed this time. Clinical results DMB-3115 showed bioequivalence with Stellara in terms of pharmacokinetic parameters, and there was no significant difference in safety and immunogenicity."

P1 data • Immunology