SB36 (vedolizumab biosimilar) / Samsung, Sandoz - LARVOL DELTA

Cancer Risk with Advanced Therapies in Patients with Inflammatory Bowel Diseases: An Administrative Claims-based Study. (PubMed, Clin Gastroenterol Hepatol) - "In a real-world cohort of 15,687 patients with IBD initiating ATs, risk of incident cancer was low and comparable across advanced therapy classes."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Bowel Disease • Lymphoma • Melanoma • Non-melanoma Skin Cancer • Obesity • Skin Cancer • Solid Tumor

Real-world patterns of inflammatory bowel disease treatment across adult and pediatric populations: a nationwide cohort study in South Korea. (PubMed, Front Med (Lausanne)) - "Secondarily, among restricted adult population with at least 1 year follow-up since first advanced agent prescription, cumulative persistence at 12 months was 76.9%-88.5% across the most recently approved agents (vedolizumab and ustekinumab). These findings underscore the importance of tailoring treatment strategies according to disease subtype and age at diagnosis. Given that only tumor necrosis factor (TNF)-alpha inhibitors are currently approved for pediatric use and considering the emerging evidence regarding treatment persistence with newer agents, these findings may support consideration of expanding therapeutic options for pediatric patients."

Journal • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Pediatrics • Ulcerative Colitis

Exploratory Analysis of Vedolizumab Trough Levels in Pediatric-Onset Ulcerative Colitis (AOCC-IMKASID 2026) - "In patients with pediatric-onset ulcerative colitis, vedolizumab TLs showed limited discriminatory ability for predicting clinical remission, with a non-significant trend toward biochemical remission and an association with lower ESR levels. These findings suggest potential clinical relevance, although larger studies are needed to confirm these observations. Keywords: Vedolizumab, Trough Level, Ulcerative Colitis, Pediatric Conclusion : In patients with pediatric-onset ulcerative colitis, vedolizumab TLs showed limited discriminatory ability for predicting clinical remission, with a non-significant trend toward biochemical remission and an association with lower ESR levels."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

Cancer Risk with Advanced Therapies in Patients with Inflammatory Bowel Diseases: An Administrative Claims-Based Study (AOCC-IMKASID 2026) - " Using an administrative claims database (OptumLabs® Data Warehouse), we identified patients with IBD who initiated TNF antagonists, vedolizumab, anti-interleukins or JAK inhibitors between 2016 and 2023. In this large real-world cohort of patients with IBD initiating advanced therapies, cancer risk did not differ across AT classes and was not increased compared with newly diagnosed patients with IBD not treated with ATs or IMMs. Keywords: Inflammatory Bowel Disease, Biologics, Cancer"

Clinical • Metastases • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Inflammatory Bowel Disease • Melanoma • Oncology • Solid Tumor

Samsung Bioepis Enters into Partnership Agreement with Sandoz for Up to Five Next-Generation Biosimilar Candidates (Businesswire) - "The agreement covers up to five assets, including SB36, a biosimilar candidate referencing Entyvio (vedolizumab), for collaboration of development and commercialization in global markets excluding China, Hong Kong, Taiwan, Macau, and Republic of Korea."

Licensing / partnership • Crohn's disease • Ulcerative Colitis