Pyzchiva (ustekinumab-ttwe) / Samsung, Sandoz, NIPRO Corp, Organon - LARVOL DELTA

Hemoperfusion as Adjunctive Therapy in Severe Snake Envenomation Refractory to Antivenom: A Case Series. (PubMed, Clin Case Rep) - "All received adjunctive hemoperfusion using a Nipro HA230 cartridge via femoral venous access (six two-hour sessions over three days)...These findings suggest hemoperfusion may be a feasible adjunctive therapy in refractory cases, though the observational design precludes definitive conclusions. Hemoperfusion should be considered experimental, reserved for severe refractory cases in well-resourced settings."

Journal • Hematological Disorders

South Korea-based Samsung Bioepis has announced the marketing approval of Ustekinumab BS Intravenous Infusion 130mg, a biosimilar referencing Stelara (ustekinumab), indicated for an induction therapy for moderate-to-severe active Crohn’s disease where other treatments are ineffective (Biospectrumasia) - "This is a second product to be approved in Japan under partnership with Nipro Corporation."

Japan approval • Crohn's disease

Optimising long-term vascular access: role of the Safetouch Huber Infusion Set in implantable port management. (PubMed, Br J Nurs) - "This article provides an overview of central venous access devices, with a particular focus on the benefits of implantable ports for long-term care and the role of the Safetouch Huber Infusion Set in facilitating access to implantable ports. Use of the Safetouch Huber Infusion Set is further illustrated in two real-world case studies."

Journal • Pulmonary Disease • Respiratory Diseases

Ustekinumab originator to biosimilar switch: no adverse impact on inflammatory bowel disease control and well tolerated in a multicentre study (BSG 2026) - "Prior treatment exposure was anti-tumour necrosis factor agents (anti-TNF) in 442 (81%) patients, vedolizumab in 28 (5%) patients and both anti-TNF and vedolizumab in 59 (11%) patients...Biosimilar ustekinumab was well tolerated and appears safe. This cohort will be evaluated again for 12-month outcomes. View this table: View inline View popup Abstract P213 Table 1 Disease activity indices before switch and early after switch"

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

What is Same and Different? Clinical Value of the Ustekinumab Biosimilar SB17 (EPYZTEK®) (AOCC-IMKASID 2026) - "SB17 has demonstrated biosimilarity to reference ustekinumab through a comprehensive evidence-based development program. In addition to maintaining comparable efficacy, safety, and immunogenicity, SB17 offers potential economic and practical advantages that may support broader access to biologic therapy and improve long-term healthcare sustainability."

Clinical • Immunology • Inflammation • Plaque Psoriasis • Psoriasis

Current Status and Treatment Trends of IBD in Korea (AOCC-IMKASID 2026) - "In addition, biosimilars of adalimumab (Adaloce, Yuflyma) and ustekinumab (Epyztek, Steqeyma) became available, improving treatment accessibility and reinforcing the shift toward more cost-effective care. Currently, advanced therapies available in Korean patients with CD are infliximab, adalimumab, vedolizumab, ustekinumab, and upadacitinib, in patients with UC are infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, filgotinib, upadacitinib, and ozanimod. Collectively, these developments broadened therapeutic options and increased the complexity of clinical decision-making, prompting greater interest in treatment sequencing, switching strategies, combination regimens, and personalized approaches."

Inflammatory Bowel Disease

From Evidence to Experience: Real-World Application of Ustekinumab Biosimilar in Inflammatory Bowel Disease (AOCC-IMKASID 2026) - "This lecture aims to evaluate the efficacy, safety, and therapeutic persistence of the ustekinumab biosimilar (Epyztek®) in real-world clinical settings using a structured case-based analysis framework for patients with inflammatory bowel disease. Keywords: Ustekinumab biosimilar; Crohn's disease; ulcerative colitis; real-world evidence; treatment persistence; switching; IL-12/23 inhibitor"

Clinical • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A • IL23A

Experience with eribulin administration as a second-line treatment for recurrent breast cancer in breast clinics. (JBCS 2026) - "Postoperatively, the patient received oral letrozole + UFTE, but multiple liver and bone metastases appeared after approximately 2 years. Faslodex + Verzenio (+ Xgeva) was started as first-line treatment in October 2024...On the day of administration, after checking blood count, white blood cell differential, biochemistry, CRP, and chest X-ray, and considering economic factors, eribulin mesylate 1 mg "Nipro" (+ 100 ml saline) was administered peripherally in the infusion room...To date, there have been no hematological toxicity or peripheral neuropathy, and no adverse events other than hair loss have been observed, indicating safe administration. We will report on future treatment effects and administration details with some literature review."

Clinical • Alopecia • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Dual-action combined glucose and beta-ketone monitoring in diabetes care with Nipro's 4SURE Smart Duo. (PubMed, Br J Nurs) - "This article examines the clinical utility of this dual approach, focusing on the Nipro 4SURE Smart Duo system, a device validated to exceed the latest ISO accuracy standards. By offering accurate, real-time beta-ketone measurement alongside glucose readings, this technology allows PLwD to detect and prevent life-threatening conditions like diabetic ketoacidosis earlier, enhancing patient safety and improving clinical outcomes."

Journal • Diabetes • Metabolic Disorders

Samsung Bioepis and Organon…announced the expansion of their development and commercialization agreement, whereby Organon will obtain commercialization rights in Canada to PYZCHIVA, Samsung Bioepis’s biosimilar referencing STELARA (ustekinumab) (Businesswire) - "Under the terms of the agreement, Organon will obtain exclusive commercial rights to the product in Canada while Samsung Bioepis will maintain full development, manufacturing, and regulatory responsibilities. This agreement expands the biosimilar portfolio under Organon and Samsung Bioepis’s collaboration in Canada from five to six complementary products....PYZCHIVA is expected to be launched in the market in 2026."

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

Blood Volume Management as a Haemodynamic Compass for Tailored Dialysis (ERA 2026) - "Method Patients underwent a 2 ‑ week run ‑ in period to determine the individual blood volume change per kg of UF rate (BVC/UF) for each patient, followed by 10 weeks of BVC ‑ guided UF dialysis (Surdial X, Nipro)...A larger patient cohort and a longer follow ‑ up period are required to detect significant changes in NT ‑ proBNP levels and blood pressure control. Image Figure 1: example of an active BVM module for combined control of UF rate and dialysate sodium conductivity."

Diabetes • Hypotension • Metabolic Disorders

Profiling cardiac Troponin between dialysis filter types. A pilot study. (ERA 2026) - "Table Hematology: TNT Corrected [ng/ml] by Dialysis Data: Filter N Mean 95% CI * Mean SE * SD CV Evodial 1,6 2 176,82 109,35 to 244,28 33,918 62,49 35,3% FMC FX 100 2 100,61 33,15 to 168,07 33,918 1,97 2,0% FMC FX CorAl 80 10 36,91 6,74 to 67,08 15,169 21,70 58,8% FMC FX CorAl 100 14 63,51 38,02 to 89,01 12,820 18,58 29,2% FMC FX CorAl 800 8 93,84 60,11 to 127,57 16,959 58,44 62,3% FX 80 Classix 10 219,24 189,07 to 249,41 15,169 100,11 45,7% FX 100 Classix 6 86,95 48,01 to 125,90 19,582 33,26 38,2% FX Cordiax 80 8 59,70 25,97 to 93,43 16,959 9,80 16,4% FX Cordiax 100 12 92,90 65,36 to 120,44 13,847 40,08 43,1% FX Cordiax 800 2 44,25 -23,21 to 111,71 33,918 8,99 20,3% Nipro Elisio 21H 8 72,73 39,00 to 106,46 16,959 43,49 59,8% Nipro Solacea 19H 2 45,37 -22,09 to 112,83 33,918 14,75 32,5% RevaClear 300 12 86,92 59,38 to 114,46 13,847 49,38 56,8% Pooled 96 47,97 * Standard error of the mean based on the pooled sample variance. Image"

Clinical • Hematological Disorders • Renal Disease

Evaluation of the Effect of the Dialysis Membrane Material on the Anticoagulant Efficacy of an NO-supplemented Dialysate in a Rat Hemodialysis Model (ERA 2026) - "Male Sprague-Dawley rats weighing 300–500 g were anesthetized with isoflurane (1.5–3.0%)...Prototype dialyzer modules manufactured by Nipro Corporation with either PES or CTA membranes (membrane surface area: 0.014 m²; 140 hollow fibers) were used...NO-supplemented dialysate exerted anticoagulant effects regardless of the dialysis membrane material used, suggesting that NO-supplemented dialysate consistently exerts anticoagulant effects independent of the membrane material used. Conclusion NO-supplemented dialysate exerted anticoagulant effects regardless of whether a PES or CTA membrane was used, although the effect was more pronounced with the CTA membrane."

Preclinical • Hypotension • Thrombosis

Baseline-Dependent Reduction of Beta-2 Microglobulin During Hemodiafiltration: A Multicenter Longitudinal Study (ERA 2026) - "Twenty patients were dialysed with a polysulfone membrane (PS, Fx 100, Fresenius) and twenty with an asymmetric triacetate membrane (ATA, Solacea 21H, Nipro)...The trend line illustrates the concentration- dependent behaviour of B2M, crossing 0-line at 24-27 mg/dL. B2M, beta-2 microglobulin; ΔB2M, monthly change in B2M"

Clinical • Longitudinal study • Observational data • B2M

Samsung Bioepis Co., Ltd. May 20, announced the launch of Ustekinumab BS 45 mg Syringe for S.C. Injection, a biosimilar referencing Stelara (ustekinumab), marking its first product launch in Japan under partnership with NIPRO CORPORATION (Business Korea) - "The launch follows the Official Gazette announcement on May 19 regarding the product’s listing under the National Health Insurance (NHI) Drug Price Standard, which became effective today....Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has granted marketing authorization to Ustekinumab BS 45 mg Syringe for S.C. Injection for the treatment of plaque psoriasis, and psoriatic arthritis in December 2025."

Biosimilar launch • Psoriasis • Psoriatic Arthritis

CVS Caremark to remove Stelara from commercial formularies (Managed Healthcare Executive) - "Beginning July 1, 2026, CVS Caremark will transition from Stelara (ustekinumab) on its most common commercial template formularies to preferring the interchangeable biosimilars Pyzchiva and Yesintek. Most members will pay $0 out-of-pocket....Stelara and its biosimilars treat patients with psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis."

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

Samsung Bioepis Releases Second Quarter 2026 US Biosimilar Market Report (Businesswire) - "Adalimumab and ustekinumab biosimilars are gaining traction, with market shares reaching 60% and 27%, respectively...As of the second quarter of 2026, the average ASP of ustekinumab biosimilars had declined to $753, representing a 73% decrease from the previous quarter. This sharp decline was primarily attributable to revisions in ASP calculations for several ustekinumab biosimilars, which were adjusted to reflect only the price of the initial intravenous loading dose which falls under Medicare Part B....The two eculizumab biosimilars — Bkemv and Epysqli — are respectively discounted 9% and 32% below the reference product’s ASP, reflecting divergent pricing strategies."

Sales • Ankylosing Spondylitis • Atypical Hemolytic Uremic Syndrome • Crohn's disease • Hidradenitis Suppurativa • Idiopathic Arthritis • Immunology • Myasthenia Gravis • Paroxysmal Nocturnal Hemoglobinuria • Plaque Psoriasis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

PBAC Recommends PBS Reimbursement for Biosimilars to Adalimumab (High Concentration), Omalizumab (PFP) & Ustekinumab (Pearce IP) - "At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement of the following biosimilars: Amgen’s Amgevita (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP); Celltrion’s Yuflyma (adalimumab) in 20mg/0.2ml PFS; Celltrion’s Omlyclo (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP; Sandoz’s Ardelya (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS; Amgen’s Wezlana (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS and 130 mg in 26 mL solution for IV infusion."

Reimbursement • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Crohn's disease • Hidradenitis Suppurativa • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Switching from ustekinumab originator to biosimilar: No adverse impact on inflammatory bowel disease control and well tolerated by patients in a UK multicentre study (ECCO-IBD 2026) - "Prior treatment exposure was anti-tumour necrosis factor agents (anti-TNF) in 440 (81%) patients, vedolizumab in 89 (16%) patients and both anti-TNF and vedolizumab in 65 (12%) patients. Biosimilar ustekinumab was well tolerated and appears to be safe. Biosimilar evaluation will continue with the 12-month review of this cohort."

Clinical • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Risankizumab versus reference and biosimilar ustekinumab in moderate-to-severe Crohn’s disease: A cost-effectiveness model from the German perspective (ECCO-IBD 2026) - "Sensitivity analysis showed at a willingness to pay threshold of €35,000 (assumed to be NICE upper threshold of £30,000 converted to Euros), the probability of risankizumab being cost-effective was 0% compared to both reference and biosimilar ustekinumab (Figure 1). Conclusion Using clinical data from SEQUENCE trial, results from the cost-effectiveness model indicate that reference ustekinumab is more cost effective than risankizumab for moderate-to-severe CD with previous TNFα failure, which is more marked with biosimilar ustekinumab due to lower cost."

Cost effectiveness • HEOR • Crohn's disease • Immunology • Inflammatory Bowel Disease • IL12A • TNFA

Short and medium-term outcomes of ustekinumab biosimilar in patients with Crohn’s Disease (ECCO-IBD 2026) - "No adverse event was observed. Conclusion Administration of the ustekinumab biosimilar appears to be both safe and effective when initiated in UST-naive patients or following switch from originator ustekinumab in CD patients."

Clinical • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Samsung Bioepis…announced on the 14th that the pre-filled pen formulation (PFP) of the autoimmune disease treatment Stelara biosimilar 'Epiztec (ingredient: ustekinumab)' received product approval from the Ministry of Food and Drug Safety on the 13th. [Google translation] (HIT News)

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

Samsung Bioepis…announced the marketing approval of Ustekinumab BS Subcutaneous Injection 45mg Syringes 'NIPRO', a biosimilar referencing Stelara (ustekinumab), developed by Samsung Bioepis (Businesswire) - "‘NIPRO’ has been approved for the treatment of plaque psoriasis, and psoriatic arthritis. The product is set to be listed in the Japan’s National Health Insurance (NHI) drug list in May 2026, allowing for commercialization by NIPRO immediately after drug listing."

Biosimilar launch • Japan approval • Psoriasis • Psoriatic Arthritis

Pyzchiva (ustekinumab-ttwe): A New Biosimilar for Psoriasis. (PubMed, Ann Pharmacother) - "Ustekinumab-ttwe's equivalence to its reference biologic ustekinumab creates another treatment option for patients with moderate- to- severe plaque psoriasis."

Journal • Review • Dermatology • Immunology • Psoriasis

Samsung Bioepis Reaches Settlement Agreement for PYZCHIVA (ustekinumab) in Europe (Business Korea)

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