Hyrimoz (adalimumab-adaz) / Sandoz - LARVOL DELTA

Sandoz Supplemental Biologics License Application accepted by US FDA for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation (HCF) (Sandoz Press Release) - "The application includes the indications of the reference medicine Humira (adalimumab) not protected by orphan exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis....In accordance with recommendations from the US FDA, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL and citrate-free Hyrimoz HCF."

FDA filing • Ankylosing Spondylitis • Crohn's disease • Idiopathic Arthritis • Immunology • Plaque Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Efficacy, Immunogenicity and Safety of Various Biosimilar Tumor Necrosis Factor Inhibitors in Ocular inflammatory diseases (ARVO 2025) - "Ten patients were on adalimumab biosimilars (6 Hyrimoz, 2 Hadlima, 1 Cyltezo, 1 Amjevita), and one was on infliximab biosimilar (Inflectra). Describe the big picture and the implications of your findings, not the study itself and the associated details. This study assesses the efficacy, immunogenicity and safety of tumor necrosis factor inhibitor biosimilars in ocular inflammatory disease, to evaluate their potential as a more affordable alternative to reference products and broaden access to biologics."

Clinical • Ocular Inflammation • Ophthalmology • Uveitis

Early real-world utilization of ADA-adaz (Hyrimoz) in the United States: A retrospective claims-based descriptive study. (PubMed, Medicine (Baltimore)) - "Adalimumab (ADA)-adaz (Hyrimoz®; Sandoz, Inc.) became available in the United States (US) in July 2023. Among patients with available short-term follow-up, adherence while on ADA-adaz was high. Further studies with longer follow-up can assess ADA-adaz utilization patterns and long-term outcomes."

Journal • Retrospective data • Cardiovascular • Crohn's disease • Dyslipidemia • Gastroenterology • Genetic Disorders • Hypertension • Immunology • Inflammatory Bowel Disease • Mood Disorders • Osteoarthritis • Pain • Psychiatry • Rheumatoid Arthritis • Rheumatology

Comparable long-term outcomes with biosimilar and originator adalimumab in juvenile idiopathic arthritis: a multicenter cohort study. (PubMed, Expert Opin Biol Ther) - "129 patients were analyzed (originator product [OP], n = 86; biosimilar product [BP], n = 43; ABP 501, n = 39; GP2017, n = 4). Remission ≥ 6 months was more frequent in OP (p = 0.039), whereas drug-free remission and adverse event rates were similar. Biosimilar adalimumab demonstrated comparable long-term outcomes to the originator, although baseline differences between groups should be considered."

Journal • Ankylosing Spondylitis • Idiopathic Arthritis • Immunology • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

ADAPT: Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial (clinicaltrials.gov) - P4 | N=160 | Not yet recruiting | Sponsor: Nisha Acharya

New P4 trial • Idiopathic Arthritis • Immunology • Ocular Inflammation • Ophthalmology • Pediatrics • Rheumatology • Uveitis

The Treat-JIA trial (clinicaltrialsregister.eu) - P4 | N=90 | Not yet recruiting | Sponsor: Oslo Universitetssykehus HF

Monotherapy • New P4 trial • Idiopathic Arthritis • Immunology • Rheumatology

2025.36: Discontinuation of disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis patients also using TNF inhibitors (clinicaltrialsregister.eu) - P4 | N=202 | Not yet recruiting | Sponsor: Sint Maartenskliniek Stichting

Head-to-Head • New P4 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Real-world safety of adalimumab biosimilar-to-biosimilar switching in >1,200 patients with inflammatory arthritis: results from the nationwide DANBIO registry (EULAR 2026) - "Objectives In patients with RA, PsA and axSpA who switched from SB5 to GP2017 in routine care, we aimed to explore the incidence rates (IRs) of serious infections, venous thromboembolic events (VTEs), allergic reactions, and death during the first two years (0-12 and 0-24 months, respectively) of GP2017 treatment...Sandoz had no influence on the data collection, statistical analyses or preparation of this abstract and had no access to raw data. *Kasper Yde Jensen and Hafsah Nabi are joint first author"

Clinical • Real-world • Real-world evidence • Ankylosing Spondylitis • Cardiovascular • Immunology • Infectious Disease • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Ocular Risks of Adalimumab Biosimilars Through a National Analysis (ARVO 2026) - "We performed deduplication, case expansion, and classification into original (adalimumab) and biosimilar (adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm adalimumab-afzb, adalimumab-aqvh, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp, and adalimumab-ryvk). These findings do not prove the drugs cause these issues, but they highlight areas for doctors and patients to watch more closely. Improving our understanding of biosimilar safety helps ensure patients receive effective treatment with the lowest possible risk."

Ophthalmology

ADALIMUMAB BIOSIMILAR UPTAKE IN US MEDICAID: AN ANALYSIS OF MANAGED CARE VS. FEE-FOR-SERVICE EXPENDITURE TRENDS (2024-2025) (ISPOR 2026) - "Other biosimilars, such as Amjevita (~10% share) and Hadlima (~2% share), showed moderate uptake, while Simlandi and Hyrimoz represented a negligible portion of Medicaid reimbursement during this period. Medicaid biosimilar adoption is accelerating but follows a unique product selection trajectory distinct from major commercial PBM trends. Medicaid biosimilar adoption is accelerating but follows a unique product selection trajectory distinct from major commercial PBM trends. The significant expenditure share of Cyltezo in FFS programs suggest successful state-level or Medicaid-specific contracting strategies that differ from the broader market. These findings highlight the importance of using expenditure-based metrics over volume-based metrics when analyzing Medicaid claims to avoid artifacts from unit-of-measure discrepancies."

Medicaid • Reimbursement • US reimbursement

Cost and Treatment Efficacy of Reference and Biosimilar Biologics in Pediatric Non-Infectious Uveitis (ARVO 2026) - "Methods Twenty-four patients (0–18 years) with PNIU treated with infliximab-dyyb, adalimumab-bwwd, or adalimumab-adaz between 2017 and 2024 at a large tertiary care center were included. A significant number of patients discontinued the biosimilar medication due to adverse effects or treatment failure. Costs were significantly lower for the biosimilar medications."

Clinical • Ocular Inflammation • Ophthalmology • Uveitis

Superior Clinical and Economic Value of IL-23 Inhibitors Versus Adalimumab Biosimilars in Plaque Psoriasis. (PubMed, Int J Dermatol) - "Our study highlights the substantial clinical benefit of IL-23 inhibitors over adalimumab biosimilars, with guselkumab as the more cost-effective option than the other IL-23 inhibitors for the real-world management of moderate-to-severe psoriasis."

Journal • Dermatology • Immunology • Psoriasis • IL23A

Comparing the pharmacokinetics of adalimumab originator and biosimilar product in patients with Inflammatory bowel disease or autoimmune disease. (PubMed, Saudi Pharm J) - "Patients received various adalimumab products, including the reference biologic (Humira, 70.7%) and biosimilars (Amgevita, 16.2%; Hyrimoz, 13.1%). No significant differences in clearance were observed, suggesting comparable clearance. The adoption of biosimilars in clinical practice could improve patient access to biologic therapies while substantially reducing healthcare costs."

Journal • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Comparison of treatment with GP2017 (an adalimumab biosimilar) and reference adalimumab in people with plaque psoriasis: a plain language summary of the ADACCESS trial. (PubMed, Immunotherapy) - No abstract available

Journal • Dermatology • Immunology • Psoriasis

Effectiveness and safety of adalimumab biosimilar in bio-naive patients with inflammatory bowel disease: a real-life multicenter observational study comparing ABP501, SB5, MSB11022, GP2017, and FKB327. (PubMed, Crohns Colitis 360) - "Furthermore, there is no significant difference between the 5-ADA biosimilars. Drug persistence was significantly higher in patients with CD treated with IMM and with post-induction ADA levels ≥7 μg/mL."

Journal • Observational data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Major U.S. Formulary Change Triggers, but Does Not Sustain, Increases in Biosimilar Adalimumab Prescribing. (PubMed, Arthritis Care Res (Hoboken)) - "While biosimilar adalimumab prescriptions rose sharply after a major national formulary change, the increase was not sustained. These findings highlight that persistent barriers, including the nocebo effect and the administrative burden of switching, may continue to limit biosimilar adoption and contribute to the loss of substantial cost savings in the US market."

Journal • Rheumatology

Safety and Effectiveness of Multi-Switch between Adalimumab Originator and Biosimilars in Inflammatory Bowel Disease: A Multicenter (SUSTAIN) Study (ECCO-IBD 2026) - "Adult patients receiving adalimumab-adaz, or adalimumab-atto were included. Conclusion Multiple switches of adalimumab biosimilars can be safely undertaken without increasing the risk of adverse reactions, or treatment failure. Our study provides meaningful evidence to guide policy, resource allocation, and clinician confidence in biosimilar interchangeability as a sustainable therapeutic strategy in IBD mansagement."

Clinical • Immunology • Inflammation • Inflammatory Bowel Disease

Possible Involvement of β1-Adrenoceptors in the Positive Chronotropic Effects of Mirabegron. (PubMed, Biol Pharm Bull) - "Isoproterenol (0.1-100 nM), a nonselective β-adrenoceptor agonist, dobutamine (0.001-100 μM), a β1-adrenoceptor agonist, and salbutamol (0.001-100 μM), a β2-adrenoceptor agonist, induced concentration-dependent positive chronotropic effects, with the potency order of isoproterenol > dobutamine > mirabegron ≥ salbutamol in mice, and isoproterenol > dobutamine ≥ salbutamol > mirabegron in guinea pigs. Conversely, the selective β1-adrenoceptor antagonist CGP20172A (0.03-3 nM) strongly and non-competitively antagonized mirabegron-induced positive chronotropic effects in mouse and guinea pig atria. These results suggest that the positive chronotropic effects of mirabegron are primarily mediated through β1-adrenoceptors, with minimal or no involvement of β2- and β3-adrenoceptors."

Journal • Overactive Bladder

Safety and Effectiveness of Multi-Switch Between Adalimumab Originator and Biosimilars: A Multicenter (SUSTAIN) Study. (PubMed, J Clin Med) - "Adult patients receiving adalimumab-adaz or adalimumab-atto were included. Multiple switches of adalimumab biosimilars can be safely undertaken without increasing the risk of adverse reactions or treatment failure. This study provides meaningful evidence to guide policy and physician confidence in biosimilar interchangeability as a sustainable IBD therapeutic strategy."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Perforating dermatosis in a young female patient receiving adalimumab biosimilar CTP-17 for chronic plaque psoriasis: A case report. (PubMed, SAGE Open Med Case Rep) - "A 34-year-old woman with psoriasis and psoriatic arthritis developed acquired perforating dermatosis after switching from adalimumab biosimilar GP2017-CTP17...Both conditions were later managed with methotrexate and ixekizumab...Early recognition and discontinuation may prevent progression. Further studies are needed to clarify pathogenesis."

Journal • Cognitive Disorders • Dermatology • Diabetes • Immunology • Infectious Disease • Inflammatory Arthritis • Metabolic Disorders • Oncology • Pain • Psoriasis • Psoriatic Arthritis • Renal Disease • Rheumatology • Seronegative Spondyloarthropathies

O05 A retrospective review of cases of psoriasis requiring discontinuation of biologic therapy from 2007 to 2024 in a multisite NHS trust. (PubMed, Br J Dermatol) - "Concurrent systemic immunosuppression (methotrexate or ciclosporin) was prescribed in 21% (n = 31)...The biologics with most interventions were adalimumab or biosimilars (n = 102: Humira n = 39, Idacio n = 30, Hyrimoz n = 23, Amgevita n = 10), ustekinumab (n = 39), secukinumab (n = 35), guselkumab (n = 13) and certolizumab (n = 11)...The main blood abnormality was positive tuberculosis ELISpot assay (interferon-γ release assay) (n = 6: Humira n = 2; and Idacio, ustekinumab, etanercept and risankizumab n = 1 each). Other abnormalities included leucocytosis in sepsis (n = 2; ustekinumab, secukinumab), neutropenia (n = 1; Hyrimoz), raised alanine aminotransferase (n = 1; Humira) and raised fetal calprotectin (n = 1; Ixekizumab)...Blood abnormalities requiring treatment intervention were infrequent, most commonly positive tuberculosis testing. Our findings support reducing blood monitoring of..."

Journal • Retrospective data • Atopic Dermatitis • Dermatology • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Neutropenia • Pain • Psoriasis • Psoriatic Arthritis • Pulmonary Disease • Respiratory Diseases • Rheumatology • Septic Shock • Seronegative Spondyloarthropathies • Tuberculosis • Type 2 Diabetes Mellitus • Ulcerative Colitis • Urticaria • IFNG

HYRISS: Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting (clinicaltrials.gov) - P=N/A | N=562 | Active, not recruiting | Sponsor: Sandoz | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Anti-Tumor Necrosis Factor-Associated IgAN (KIDNEY WEEK 2025) - "On Humira since 2017, switched to Hyrimoz in 2024, with no Crohn’s flares since 2017...Anemic (Hb 10 g/dL) with worsening microscopic hematuria and new proteinuria (2g/g, improved to 1.3g/g with Lisinopril)...Infliximab has also been known to cause IgA Nephropathy in patient with Pustular Psoriasis as well as Ankylosing Spondylitis. It is important for a patient treated with Adalimumab for Crohn's Disease to have frequent follow ups with their renal function tests to monitor for TNF alpha inhibitor induced renal dysfunction, early diagnosis and treatment of which can be life saving."

Ankylosing Spondylitis • Back Pain • Chronic Kidney Disease • Crohn's disease • Dermatology • Gastroenterology • Glomerulonephritis • IgA Nephropathy • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Lumbar Back Pain • Musculoskeletal Pain • Nephrology • Oncology • Pediatrics • Psoriasis • Pustular Psoriasis • Renal Disease • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • TNFA

Price Behavior of Originator Adalimumab After Biosimilars Entry: Evidence From the Colombian Market (ISPOR-EU 2025) - "Biosimilars (Amgevita®, Idacio®, and Hyrimoz®) were included from their respective market entry dates. Prices of originator adalimumab declined steadily after biosimilar entry, with similar trends observed for biosimilars. These findings suggest that biosimilar competition contributes to cost containment and plays a key role in improving access and promoting sustainability within the colombian health system."

Real World Rate of Efficacy of Adalimumab Biosimilars Following a Mandated Switch in an Academic Medical Center (ACR Convergence 2025) - "Rheumatoid arthritis was the most common diagnosis (32.1%) Across the 18-month time period, 97 patients (9.6%) were switched to a biosimilar with adalimumab-adaz and adalimumab-bwwd most common. Real world experience following mandated switch from adalimumab to a biosimilar showed a marginally higher rate of discontinuation than comparable cohorts from outside the United States. The cost of medication saved by switching to biosimilar medications may justify this rate of unanticipated mediation interruption."

Clinical • Real-world • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology