the goal of this study is to compare the efficacy of ustekinumab with infliximab for the treatment of ulcerative colitis aim of the study :
1. Compare effectiveness of ustekinumab versus infliximab therapy in remission achievement in UC patients.
2. Compare safety of ustekinumab therapy versus infliximab therapy in UC
3. To asses quality of life of ustekinumab therapy versus infliximab therapy in UC patients.

Start Date15 May 2025

Sponsor / Collaborator

Helwan University

NCT06788340

/ Not yet recruitingPhase 4IIT

MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - an Independent Randomized Controlled Trial

The goal of this clinical trial is to investigate if dosage of Ustekinumab (UST) and Vedolizumab (VDZ) based on Model-Informed Precision Dosing (MIPD) is equally as efficient in keeping adults with Inflammatory Bowel Disease (IBD) in remission as management based on what the treating physician deems best. The main question is:
Is using pharmacokinetic-pharmacodynamic (PK-PD) models to predict the appropriate dose and dosing interval for VDZ and UST at least as effective as current practices in maintaining IBD remission.
As above mentioned the comparison-group is adults with IBD, treated with UST or VDZ, managed as the physician deems best.
Participants will:
Have blood and stool tests done, as well as answer a questionnaire 4th weekly Have their dosage frequency decided on either by the PK-model or as the physician deems best visit the clinic once every 24 weeks for checkups. Have an endoscopy done at completion of the study (if the disease is primarily located in the small intestine, MRI or capsule endoscopy will be used instead)

Start Date01 May 2025

Sponsor / Collaborator

Odense University Hospital

100 Clinical Results associated with Ustekinumab

100 Translational Medicine associated with Ustekinumab

100 Patents (Medical) associated with Ustekinumab

3,437

Literatures (Medical) associated with Ustekinumab

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost per remission for mirikizumab versus ustekinumab for moderately to severely active ulcerative colitis treatment from the United States commercial payer perspective

Article

Author: Upadhyay, Navneet ; Creveling, Thomas ; Fisher, Deborah A. ; Mittal, Neha ; Chanan, Neha ; Bires, Nicholas ; Kane, Sunanda ; Gulati, Ankit ; Koushik, Amit Kumar

INTRODUCTION:

Mirikizumab, approved for the treatment of moderately to severely active ulcerative colitis (UC), may be prescribed in a similar placement to ustekinumab in second-line settings. Payers may compare the economic value when making formulary decisions. This study estimated and compared the cost per remission of the second-line therapies mirikizumab versus ustekinumab in patients with UC.

METHODS:

An Excel-based analytic model was developed to estimate the cost per additional patient achieving clinical remission at the end of one year in biologic/Janus kinase inhibitor (JAKi)-experienced patients (second-line therapy) with UC from a United States commercial payer perspective. A network meta-analysis of published pivotal randomized clinical trials was used to derive the number needed to treat (NNT) for clinical response, clinical remission, and endoscopic remission/endoscopic improvement/mucosal healing for ustekinumab and mirikizumab in the study population. The model included the treatment cost (wholesale acquisition costs [WAC] and treatment administration costs) during the induction and maintenance phases. A scenario involving the availability of a ustekinumab biosimilar was also evaluated, assuming the NNT remained the same as ustekinumab but with a WAC set at 50% lower than its current WAC.

RESULTS:

The costs per patient achieving clinical remission for mirikizumab vs. ustekinumab as a second-line therapy were $461,096 vs. $67,273 during induction and $501,456 vs. $1,079,189 during maintenance. The cost per clinical remission in case of dose escalation during maintenance was lower for mirikizumab vs. ustekinumab ($501,456 vs. $1,569,127). Considering the ustekinumab 130 mg IV biosimilar, the scenario resulted in a lower cost per clinical remission for mirikizumab vs. a ustekinumab biosimilar during the maintenance phase ($501,456 vs. $539,594).

CONCLUSION:

Mirikizumab is projected to have a lower cost per remission during maintenance therapy than ustekinumab. Given the need for long-term treatment for this chronic condition, mirikizumab appears to be a cost-efficient treatment option.

01 Dec 2025·IMMUNOLOGIC RESEARCH

A patient with CVID-enteropathy successfully treated with ustekinumab

Article

Author: Grammatikos, Alexandros ; Marley, Fenella ; Lockett, Melanie ; Gompels, Mark

CVID (common variable immunodeficiency) is associated with a variety of gastrointestinal disorders including those mimicking Crohn's disease and ulcerative colitis. At present there is no clear trial data for the treatment of CVID enteropathy. There are no specific recommendations for treatment; however, it is commonly treated in a similar manner to inflammatory bowel disease, with corticosteroids, 5-aminosalicylates (5-ASA), azathioprine and anti-TNF therapy all being used. We describe the case of a 54-year-old with CVID-enteropathy presenting with diarrhoea and evidence of granulomatous inflammation on colonic biopsies. He was successfully treated with ustekinumab following failure/intolerance of prednisolone, 5-ASA and azathioprine. Features of CVID-enteropathy improved both clinically and histologically, with no evidence of serious treatment-related side effects.

04 Aug 2025·JOURNAL OF EXPERIMENTAL MEDICINE

Immunopathological and microbial signatures of inflammatory bowel disease in partial RAG deficiency

Article

Author: Pasic, Srdjan ; Villa, Anna ; Yilmaz, Melis ; Riley, Deanna ; Smith, Grace ; Corsino, Cristina ; Lim, Ai Ing ; Lionakis, Michail S. ; Oguz, Cihan ; Dimitrova, Dimana ; Segre, Julia A. ; Belkaid, Yasmine ; Pala, Francesca ; Licciardi, Francesco ; Delmonte, Ottavia M. ; Freeman, Alexandra F. ; Bohrnsen, Eric ; Brigatti, Karlla W. ; Holland, Steven M. ; Alva-Lozada, Guisela ; Subramanian, Poorani ; Brett, Ana ; Potts, David E. ; Kimzey, Cole D. ; Pittaluga, Stefania ; Vujkovic-Cvijin, Ivan ; Bergerson, Jenna R.E. ; Ale, Hanadys ; Daley, Stephen R. ; Sharapova, Svetlana O. ; Marseglia, Gian Luigi ; Burns, Andrew S. ; Ward, Brant R. ; Strauss, Kevin A. ; Fontana, Elena ; Dos Santos Dias, Lucas ; Poskitt, Laura E. ; Ott de Bruin, Lisa ; Fink, Danielle ; Kuhns, Douglas B. ; Schwarz, Benjamin ; Dasso, Joseph F. ; Kong, Heidi H. ; Bosticardo, Marita ; Dutmer, Cullen M. ; Castagnoli, Riccardo ; Notarangelo, Luigi D. ; Walter, Jolan E. ; Oikonomou, Vasileios ; Angelova, Angelina ; Kenney, Heather

Partial RAG deficiency (pRD) can manifest with systemic and tissue-specific immune dysregulation, with inflammatory bowel disease (IBD) in 15% of the patients. We aimed at identifying the immunopathological and microbial signatures associated with IBD in patients with pRD and in a mouse model of pRD (Rag1w/w) with spontaneous development of colitis. pRD patients with IBD and Rag1w/w mice showed a systemic and colonic Th1/Th17 inflammatory signature. Restriction of fecal microbial diversity, abundance of pathogenic bacteria, and depletion of microbial species producing short-chain fatty acid were observed, which were associated with impaired induction of lamina propria peripheral Treg cells in Rag1w/w mice. The use of vedolizumab in Rag1w/w mice and of ustekinumab in a pRD patient were ineffective. Antibiotics ameliorated gut inflammation in Rag1w/w mice, but only bone marrow transplantation (BMT) rescued the immunopathological and microbial signatures. Our findings shed new light in the pathophysiology of gut inflammation in pRD and establish a curative role for BMT to resolve the disease phenotype.

475

News (Medical) associated with Ustekinumab

27 May 2025

·www.prnewswire.com

Bio-Thera Solutions and Hikma Pharmaceuticals announce FDA approval of STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing STELARA® (ustekinumab) Injection

GUANGZHOU, China and LONDON, May 27, 2025 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing Stelara® (ustekinumab) Injection. STARJEMZA® is Bio-Thera's third FDA approved product. Bio-Thera and Hikma entered into a license and commercialization agreement for STARJEMZA® in August 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Hikma is responsible for the commercialization of STARJEMZA® in the United States. "The approval of STARJEMZA® is another significant accomplishment for Bio-Thera, establishing Bio-Thera as a premier global biosimilar developer and manufacturer," said Shengfeng Li, CEO at Bio-Thera. "As our third FDA approved biosimilar, STARJEMZA® demonstrates Bio-Thera's commitment to developing more biosimilars, expanding patient access to important therapies." "This approval and our partnership with Bio-Thera enables us to strongly enter the U.S. biosimilar market, building on our well-established position as a top-three domestic provider of sterile injectable medicines to U.S. hospitals, healthcare providers, and patients," said Dr. Bill Larkins, President of Hikma Injectables. "Tapping into the robust ongoing growth of the U.S. biosimilar market is a priority for Hikma. We are eager to use our excellent U.S. commercial capabilities to launch this important product and provide it to the many patients who will benefit from using it." The FDA approval of STARJEMZA®, originally known as BAT2206, was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Bio-Thera to the FDA. Extensive analytical characterization between STARJEMZA® and US and EU Stelara® was conducted on structural, physicochemical, and biological properties to support bio-similarity of STARJEMZA®. A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of STARJEMZA® with both the US and EU Stelara® in healthy volunteers. A multicenter, randomized, double-blind, parallel-arm, phase III study compared STARJEMZA® with Stelara® for efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis. The totality of the evidence demonstrated that STARJEMZA® has similar efficacy, safety, immunogenicity, and quality as the reference product ustekinumab. About STARJEMZA® (ustekinumab-hmny) Injection STARJEMZA® is a biosimilar to Janssen's Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 subunit from binding to the IL-12Rβ1 receptor chain of IL-12 (IL-12Rβ1/β2) and IL-23 (IL-12Rβ1/23R) receptor complexes on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation, CD4+ T-cell differentiation and following relative cytokines stimulated release. Abnormal regulation of IL-12 and IL-23 have been implicated as important contributors to chronic inflammation, including psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), and Ulcerative colitis (UC). Neutralizing human IL-12 and IL-23 by STARJEMZA® to prevent the relevant cell signaling in the Th1 or Th17 lineages can effectively block the pathologic processes of these immune disorders. About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® in the US, and BAT1806/TOFIDENCE™ (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US, a/k/a POBEVCY® in EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera). About Hikma Pharmaceuticals (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB/stable S&P and BBB-/positive Fitch) Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,500 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to STARJEMZA® /BAT2206 or the product pipelines in general of Bio-Thera Solutions and Hikma. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions and Hikma and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions and Hikma undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. 1) STARJEMZA® is a registered trademark of Hikma Pharmaceuticals USA Inc. 2) STELARA® is a registered trademark of Johnson and Johnson 3) QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. 4) BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd. 5) TOFIDENCE™ is a trademark of Organon LLC 6) AVZIVI® is a registered trademark of Sandoz 7) POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Bio-Thera Contacts Bio-Thera Solutions, Ltd.: Bert E. Thomas IV +1.410.627.1734 [email protected] Hikma Pharmaceuticals PLC Susan Ringdal +44 (0)20 7399 2760/ +44 7776 477050 EVP, Strategic Planning and Global Affairs Steven Weiss +1 732 788 8279 US Communications Important Safety Information for STARJEMZA® (ustekinumab-hmny) Injection CONTRAINDICATIONS STARJEMZA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STARJEMZA. WARNINGS & PRECAUTIONS Infections - Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. Avoid initiating treatment with STARJEMZA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STARJEMZA in patients with a chronic infection or a history of recurrent infection. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque Psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections. Psoriatic arthritis: cholecystitis. Crohn's disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis. Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis. Theoretical Risk for Vulnerability to Particular Infections - Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. Pre-treatment Evaluation for Tuberculosis - Evaluate patients for tuberculosis infection prior to initiating treatment with STARJEMZA. Avoid administering STARJEMZA to patients with active tuberculosis infection. Malignancies - Ustekinumab products are immunosuppressants and may increase the risk of malignancy. The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Hypersensitivity Reactions - Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STARJEMZA. Posterior Reversible Encephalopathy Syndrome (PRES) - Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn's disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products. Monitor all patients treated with STARJEMZA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STARJEMZA. Immunizations - Prior to initiating therapy with STARJEMZA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STARJEMZA should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with STARJEMZA or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving STARJEMZA because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of STARJEMZA may not elicit an immune response sufficient to prevent disease. Noninfectious Pneumonia - Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. If diagnosis is confirmed, discontinue STARJEMZA and institute appropriate treatment. ADVERSE REACTIONS Serious adverse reactions associated with STARJEMZA include Infections, Malignancies, Hypersensitivity Reactions, Posterior Reversible Encephalopathy Syndrome (PRES), and Noninfectious Pneumonia. Immunogenicity - Approximately 6 to 12.4% of subjects treated with ustekinumab in plaque psoriasis and psoriatic arthritis clinical trials developed antibodies to ustekinumab, which were generally low-titer. In plaque psoriasis clinical trials, antibodies to ustekinumab were associated with reduced or undetectable serum ustekinumab concentrations and reduced efficacy. In plaque psoriasis trials, the majority of subjects who were positive for antibodies to ustekinumab had neutralizing antibodies. In Crohn's disease and ulcerative colitis clinical trials, 2.9% and 4.6% of subjects, respectively, developed antibodies to ustekinumab when treated with ustekinumab for approximately one year. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen. Postmarketing Experience - The following adverse reactions have been reported during post-approval use of ustekinumab products: Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria). Infections and infestations: Lower respiratory tract infection (including opportunistic fungal infections and tuberculosis). Neurological disorders: Posterior Reversible Encephalopathy Syndrome (PRES). Respiratory, thoracic, and mediastinal disorders: Interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia. Skin reactions: Pustular psoriasis, erythrodermic psoriasis, hypersensitivity vasculitis. DRUG INTERACTIONS Concomitant Therapies - In plaque psoriasis trials the safety of ustekinumab products in combination with immunosuppressive agents or phototherapy has not been evaluated. In psoriatic arthritis trials, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In Crohn's disease and ulcerative colitis induction trials, immunomodulators (6-MP, AZA, MTX) were used concomitantly in approximately 30% of subjects and corticosteroids were used concomitantly in approximately 40% and 50% of Crohn's disease and ulcerative colitis subjects, respectively. Use of these concomitant therapies did not appear to influence the overall safety or efficacy of ustekinumab. CYP450 Substrates - The formation of CYP450 enzymes can be suppressed by increased levels of certain cytokines (e.g., IL-1, IL-6, TNFα, IFN) during chronic inflammation. Thus, use of ustekinumab products, antagonists of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. A CYP-mediated drug interaction effect was not observed in subjects with Crohn's disease. Allergen Immunotherapy - Ustekinumab products have not been evaluated in patients who have undergone allergy immunotherapy. Ustekinumab products may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis. INDICATIONS AND USAGE STARJEMZA is indicated for the treatment of: adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. adults and pediatric patients 6 years of age and older with active psoriatic arthritis. adult patients with moderately to severely active Crohn's disease. adult patients with moderately to severely active ulcerative colitis. For additional Important Safety Information, please refer to the Package Insert for full prescribing information, available on . To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800 FDA-1088 or . For Product Inquiry call 1-877-845-0689. Manufactured by: Bio-Thera Solutions, Ltd. 155 Yaotianhe Street, Huangpu District, Guangzhou, Guangdong, China 511356 Distributed By: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 USA HK-3278-v1 SOURCE Hikma Pharmaceuticals USA Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalLicense out/inPhase 3Phase 1

26 May 2025

·pharma.economictimes.indiatimes.com

Biocon Biologics psoriasis biosimilar receives UK regulator nod

Bengaluru: Biocon Biologics, the biosimilars arm of Biocon has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Yesintek , a biosimilar for psoriasis. The approved drug is a biosimilar of blockbuster drug Stelara (ustekinumab) marketed by Janssen Biotech, a subsidiary of US giant Johnson and Johnson and is one of the key sales drives of the company. As per the company's annual financial results in 2024, Stelara reported total sales of around $10.4 billion. Yesintek is a monoclonal antibody that targets two proteins—Interleukin-12 (IL-12) and Interleukin-23 (IL-23)--- to regulate the immune response and control chronic inflammation. The drug is indicated for treatment of adults and children aged 6 years and older with moderate to severe plaque psoriasis, and adults with active psoriatic arthritis or moderately to severely active Crohn’s disease. Besides this, the drug is already launched in the US and the European Commission (EC) has also granted marketing authorisation to the drugs, allowing its commercialization in all European Union (EU) member states and the European Economic Area (EEA). By Online Bureau ,

Drug ApprovalFinancial StatementBiosimilar

21 May 2025

·www.einpresswire.com

Sandoz launches Pyzchiva® autoinjector, first commercially available in Europe for ustekinumab biosimilars

MEDIA RELEASE Pyzchiva® first ustekinumab biosimilar in Europe commercially available in pre-filled pen (autoinjector), offering improved self-administration experience for better treatment adherence and quality of life [1-10] Autoinjector includes unique features to improve comfort, independence and convenience for patients with chronic inflammatory diseases [1-10] Launch strengthens Sandoz biosimilar leadership position in immunology and commitment to patient-centric innovation Basel, May 21, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced the European launch of its Pyzchiva®* (ustekinumab) autoinjector.[1-2] This is the first ustekinumab biosimilar in Europe commercially available in an autoinjector. Developed and registered by Samsung Bioepis, Pyzchiva® is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients aged six years and older, weighing over 60 kg.[1] The Pyzchiva® autoinjector supports a more comfortable self-administration experience [1-10] with accurate automatic dosing [1,3,4], less frequent injection pain [1,9,10], a compact design [1,3,4,6,7], and flexible storage options [1], offering the potential for improved adherence to patient treatment plans. Christophe Delenta, President Europe, Sandoz, said: “Access to medicine does not end when it reaches the hands of the patient. The Pyzchiva® autoinjector, with its thoughtful and advanced features, addresses the real-world needs of patients in managing chronic inflammatory diseases. This launch marks another important milestone as we strengthen our leadership in immunology biosimilars and reaffirm our commitment to pioneering access across Europe’s evolving healthcare landscape.” Europe has the highest prevalence of psoriasis worldwide, affecting an estimated 6.4 million people.[11-13] Inflammatory bowel diseases, such as Crohn’s disease, are also common in Europe, affecting an estimated 2.5 to 3 million people.[14] Non-adherence to biologic therapies can lead to disease progression, increased flares and reduced quality of life, while contributing to increased healthcare utilization, including hospitalizations and additional treatments, thereby escalating healthcare costs.[15,16] Pyzchiva® is a key biosimilar value driver for the Sandoz growth strategy. It has been launched in 23 markets in Europe. The autoinjector is now available in Spain and will continue to roll out across Europe. Sandoz entered into a development and commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva® in Brazil, the US, the European Economic Area (EEA), Switzerland and the UK. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply. ABOUT PYZCHIVA® (USTEKINUMAB) Pyzchiva® (ustekinumab) has been developed as a biosimilar with equivalent efficacy and comparable safety to the reference medicine Stelara®**, a human monoclonal antibody against interleukin (IL)-12/23. Pyzchiva® is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six years and older weighing over 60 kg. The Pyzchiva® autoinjector is a pre-filled pen delivered through the Molly®*** platform of SHL Medical AG. It is available as a 90 mg in 1 mL autoinjector or a 45 mg in 0.5 mL autoinjector.[1,2] Pyzchiva® is also available as a 130mg concentrate in a vial for solution for infusion, a 90 mg and a 45 mg concentrate solution for injection in a pre-filled syringe. *Pyzchiva® is a trademark of Samsung Bioepis Co. Ltd. **Stelara® is a trademark of Johnson & Johnson ***Pyzchiva® will be delivered by SHL Medical’s patented Molly® technology. Molly® is a registered trademark of SHL Medical AG DISCLAIMER This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law. REFERENCES [1] Pyzchiva® (ustekinumab) Summary of Product Characteristics. Available at: ema.europa.eu/en/documents/product-information/pyzchiva-epar-product-information_en.pdf (Accessed May 2025). [2] Samsung Bioepis. Data on file. [3] SHL Medical AG. Molly® autoinjector white paper. Available at: shl-medical.com/news-insights/downloads (Accessed May 2025). [4] SHL Medical AG. Molly® SE autoinjector letter. April 16, 2025. Data on file. [5] Paul C, Stalder JF, Thaçi D, et al. Patient satisfaction with injection devices: a randomized controlled study comparing two different etanercept delivery systems in moderate to severe psoriasis. J Eur Acad Dermatol Venereol . 2012;26:448–455. [6] Tischer B, Mehl A. Patients’ and nurses’ preferences for autoinjectors for rheumatoid arthritis: results of a European survey. Patient Prefer Adherence . 2018;12:1413–1424. [7] Thakur K, Sandhu SK, Sharma A. Patient Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: Findings from a Patient Survey in Europe. Rheumatol Ther . 2016;3:245–256. [8] Lopez A, Mounier M, Bouvier AM, et al.Adherence to anti-TNF therapy in inflammatory bowel diseases: a systematic review. Inflamm Bowel Dis . 2013;19:1528–1533. [9] Arendt-Nielsen L, Petersen-Felix S, Fischer M, Bak P. Pain following controlled cutaneous insertion of needles with different diameters. Somatosens Mot Res . 2006;23:37–43. [10] Gill HS, Prausnitz MR. Does needle size matter? J Diabetes Sci Technol . 2007;1:725–729. [11] International Federation of Psoriasis Associations (IFPA). Speaking up for psoriatic disease in Europe. Available at: ifpa-pso.com/content/tools/20072022_IFPA-FORUM_Briefing-Book_Speaking-up.pdf (Accessed May 2025). [12] Frede N, Gerdes S, Schön MP, et al. Psoriasis and psoriatic arthritis have a major impact on quality of life and depressive symptoms: a cross-sectional study of 300 patients. Rheumatol Ther . 2023;10:1655–1668. [13] Palfreeman AC, McNamee KE, McCann FE. New developments in the management of psoriasis and psoriatic arthritis: a focus on apremilast. Drug Des Devel Ther . 2013;7:201–210. [14] Burisch J, Jess T, Martinato M, et al. The burden of inflammatory bowel disease in Europe. J Crohns Colitis . 2013;7:322–337. [15] Vangeli E, Bakhshi S, Baker A, et al. A systematic review of factors associated with non-adherence to treatment for immune-mediated inflammatory diseases. Adv Ther . 2015;32:983–1028. [16] Maniadakis N, Toth E, Schiff M, et al. A targeted literature review examining biologic therapy compliance and persistence in chronic inflammatory diseases. Adv Ther . 2018;35:1333–1355. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. CONTACTS Global Media Relations Investor Relations Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Alex Kalomparis +41 79 279 0285 Craig Marks +44 7818 942 383 Joerg E. Allgaeuer +49 171 838 4838 Rupreet Sandhu +41 79 410 5472 Attachment Media release_Pyzchiva autoinjector European launch.pdf Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalLicense out/inImmunotherapy

100 Deals associated with Ustekinumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09214	Ustekinumab	L04AC05	DB05679

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Colitis, Ulcerative	Australia	Janssen-Cilag Pty Ltd.	28 Jul 2009
Crohn Disease	Australia	Janssen-Cilag Pty Ltd.	28 Jul 2009
Arthritis, Psoriatic	European Union	Janssen-Cilag International NV	15 Jan 2009
Arthritis, Psoriatic	Iceland	Janssen-Cilag International NV	15 Jan 2009
Arthritis, Psoriatic	Liechtenstein	Janssen-Cilag International NV	15 Jan 2009
Arthritis, Psoriatic	Norway	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active moderate	European Union	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active moderate	Iceland	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active moderate	Liechtenstein	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active moderate	Norway	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active severe	European Union	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active severe	Iceland	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active severe	Liechtenstein	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active severe	Norway	Janssen-Cilag International NV	15 Jan 2009
Plaque psoriasis	European Union	Janssen-Cilag International NV	15 Jan 2009
Plaque psoriasis	Iceland	Janssen-Cilag International NV	15 Jan 2009
Plaque psoriasis	Liechtenstein	Janssen-Cilag International NV	15 Jan 2009
Plaque psoriasis	Norway	Janssen-Cilag International NV	15 Jan 2009
Ulcerative colitis, active moderate	European Union	Janssen-Cilag International NV	15 Jan 2009
Ulcerative colitis, active moderate	Iceland	Janssen-Cilag International NV	15 Jan 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Juvenile Idiopathic Arthritis	Phase 3	United States	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	Argentina	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	Denmark	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	France	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	Germany	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	Italy	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	Poland	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	Spain	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	Turkey	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	United Kingdom	Janssen Research & Development LLC	30 Aug 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04549792 (CTgov)	Early Phase 1	Sjogren-Larsson Syndrome \| Ichthyosis	13	Ustekinumab	yookenbggo(xlwycqqoyr) = zhispuvezm xrjrqjrxyn (wfxkfknxey, 29.9) View more	-	12 Feb 2025
NCT04882072 (Phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study of ustekinumab in patients with Takayasu arteritis, CTgov)	Phase 3	Takayasu Arteritis	14	placebo+ustekinumab (Double-blind: Placebo)	jhuzpmixwz(hxkucqkyky) = wbyzmrygng vjwefwkrsz (fsderckwts, mktrthutfs - hxsgykyqak) View more	-	02 Dec 2024
				Ustekinumab (Double-blind: Ustekinumab)	jhuzpmixwz(hxkucqkyky) = qakzmsmewv vjwefwkrsz (fsderckwts, vqmmzpqfif - jevwabccvl) View more
UEGW2024	Not Applicable	Crohn Disease	-	Ustekinumab as 1st line biologic treatment	anzhhfrdub(utcerqkdyz) = 63.9% (108/169) of patients experienced adverse events vyhtmriqiu (xejzekdyef ) View more	-	13 Oct 2024
				Ustekinumab as 2nd line biologic treatment
NCT03942120 (K-STAR, Pubmed \| Inflamm Bowel Dis) Manual	Not Applicable	Crohn Disease Maintenance \| Induction	464	Ustekinumab	xoietkrcya(nmhnokexoz) = xszuyssbkj rpmxgjheco (wrulqjsskg ) View more	Positive	03 Aug 2024
				Ustekinumab (At week 52 to 66)	xoietkrcya(nmhnokexoz) = khaprkqgnk rpmxgjheco (wrulqjsskg ) View more
NCT04093531 (CTgov)	Phase 1	Primary Sjögren's syndrome	12	ustekinumab	iwojmfrfgo(kmflpnbvjr) = jlgvwvujed qiyaripbrx (heazpeuukg, puqxoxsuhx - xqoixvhbdh) View more	-	25 Jun 2024
DDW2024	Not Applicable	Colitis, Ulcerative	-	Ustekinumab	grrjlrgzxv(ofhvuusxlw) = iztwrxafpn immkjuwjhs (gnzxevjtpa ) View more	-	21 May 2024
				Vedolizumab	grrjlrgzxv(ofhvuusxlw) = vgdrjuwxtw immkjuwjhs (gnzxevjtpa ) View more
DDW2024	Not Applicable	Crohn Disease	-	Ustekinumab	enfbfmbfuo(csbjqzqlpi) = pghxbtfgdi dacxfzjmdu (aubljebego ) View more	-	20 May 2024
NCT04089345 (Pubmed \| Clin Gastroenterol Hepatol) Manual	Phase 3	Pouchitis	22	ustekinumab intravenously at baseline (∼6mg/kg)	ufxqlnhohz(xqeasilzxk) = hheecrhnko qhqnytwqhq (fowqlnjnwm ) View more	Positive	14 May 2024
NCT03981744 (CTgov)	Phase 3	Dermatomyositis	51	placebo+ustekinumab (Placebo)	nofzibgcwj = xxlvuxznci cggqkdsvce (frnevvdbxh, crmkobtivv - wczfmhgqqe) View more	-	13 May 2024
				Ustekinumab (Ustekinumab)	nofzibgcwj = kizwuslsvj cggqkdsvce (frnevvdbxh, tubqtyjvch - kxerprzkak) View more
ACR2023	Not Applicable	Arthritis, Psoriatic First line	186	UST+MTX	ndvsstsbeq(auqhewbgil) = tdqqafxwrt dwbwxiucni (xvdbczjnee ) View more	Positive	13 Nov 2023
				UST+PBO	ndvsstsbeq(auqhewbgil) = mwzzugfucr dwbwxiucni (xvdbczjnee ) View more

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