Hyrimoz (adalimumab-adaz) / Sandoz - LARVOL DELTA

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

Biosimilar adalimumab prescriptions increase before the CVS formulary change and decrease after (ACR Convergence 2025) - "CVS Caremark removed adalimumab from its national formulary in favor of adalimumab-adaz in April 2024. The CVS formulary change had a dramatic effect on prescriptions. The increase started 2 months before the official date, which likely reflects proactive changes in ordering practices by clinicians and pharmacists. The large decrease immediately after the formulary change has not been reported elsewhere."

Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Nurses' perceptions on the usability of the Hyrimoz® Sensoready® autoinjector device. (PubMed, Drugs Context) - "Visual feedback and buttonless activation were the main qualitative features driving this overall preference. Gastroenterology nurses in the USA expressed strong preferences for the Hyrimoz Sensoready pen versus the Humira pen when rating each device individually, and in direct quantitative and qualitative comparisons."

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

Impact of switching from the originator adalimumab to a biosimilar: a retrospective cohort study. (PubMed, BMC Immunol) - "The number of flares before and after switching to Hyrimoz was comparable. However, adverse effects and increased subjective complaints have been reported after switching to this new biosimilar."

Journal • Retrospective data • Immunology • Inflammation • Pain

Efficacy and safety of adalimumab biosimilar GP2017 in a 24-month treatment period for plaque psoriasis: real-life experience from Emilia-Romagna centers, Italy. (PubMed, Dermatol Reports) - "The findings confirm that GP2017 is as effective and safe as the ADA originator, supporting its use as a cost-effective alternative in the treatment of psoriasis. Biosimilars play a crucial role in promoting equitable access to biologic therapies."

Journal • Dermatology • Immunology • Psoriasis • TNFA

Retention rate of adalimumab bio-original and biosimilars in rheumatic diseases: a real world study from the Hong Kong Biologics Registry (EULAR 2025) - "boADA (Humira) accounted for 1185 and bsADA (Amgiveta or Hyrimoz) accounted for 1411 courses. The retention rate of bsADA appears to be higher than that of boADA in the treatment of inflammatory arthritis in our registry, which was mainly driven by data from patients with RA and SpA. Caution must be undertaken for interpretation of the results because the follow-up period of the bsADA was significantly shorter. A longer period of observation is necessary."

Clinical • Real-world • Real-world evidence • Ankylosing Spondylitis • Dermatology • Hepatology • Infectious Disease • Inflammatory Arthritis • Liver Failure • Oncology • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Tuberculosis

Anti-Adalimumab Antibodies Purified from Juvenile Idiopathic Arthritis Patients: Kinetic Characterization Among Biosimilars. (PubMed, Biosensors (Basel)) - "AAA interacted with Humira®, Hyrimoz®, and Imraldi® with similar apparent affinity (10-9 M > KD > 10-10 M); slight variations have been observed among patients, less among biosimilars. The similarity in KD values across biosimilars and the originator supports the notion that, at the level of immunogenicity, biosimilars can be considered clinically comparable to the originator."

Journal • Idiopathic Arthritis • Immunology • Pediatrics • Rheumatology

A comprehensive evaluation of the transition to a biosimilar of adalimumab in rheumatoid arthritis and psoriatic arthritis: a single-center experience with a focus on imaging outcomes. (PubMed, Reumatismo) - "In this analysis of the switch between oADA and bADA, no differences were found in disease activity, functional capacity, or radiographic progression. Ultrasonography indicated improvement of PD findings."

Journal • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Adalimumab Biosimilars Demonstrate Long-Term Durability and Cost-Effectiveness in Paediatric Inflammatory Bowel Disease: A Real-World Two-Centre European Cohort Study. (PubMed, Biologics) - "The biosimilars were ABP 501 (85%), GP2017 (14%), SB5 (1%); 41 (32%) patients switched from originator. Estimated cost savings were 5,030€ per patient/year. This real-life study demonstrated high durability and remission rates for adalimumab biosimilars in PIBD, confirming their clinical, cost-effectiveness and safety profile in children."

HEOR • Journal • Real-world evidence • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Inflammation • Inflammatory Bowel Disease • Lymphoma • Oncology • Pediatrics • Psoriasis • 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

Sandoz reports strong FY 2024 results and Q4 2024 sales (GlobeNewswire) - "Net sales for the fourth quarter were USD 769 million, up 25% in constant currencies. Net sales for the full year were USD 2.9 billion, up 30% in constant currencies. The biosimilars share of total net sales increased from 23% in FY 2023 to 28% in FY 2024. The strong double-digit biosimilars growth reflects the uptake of Hyrimoz in the US through the private- label agreement with...the Sandoz Hyrimoz and unbranded adalimumab-adaz. In addition...the continued strong demand for the first-ever biosimilar...and the launches of Tyruko and Pyzchiva in Europe all contributed to the strong performance."

Sales • Hidradenitis Suppurativa • Immunology • Inflammatory Bowel Disease • Ophthalmology • Rheumatoid Arthritis

Real-world Drug Survival of Biosimilar SB5 vs GP2017 Following a Mandatory Non-medical Switch from Adalimumab Originator for Psoriasis: A Nationwide Cohort Study. (PubMed, Acta Derm Venereol) - "When comparing GP2017 and SB5, no discernible differences were found in drug survival or effectiveness based on PASI. Determining drug survival and effectiveness could benefit patients and clinicians in treatment decisions."

Clinical • Journal • Real-world evidence • Retrospective data • Dermatology • Immunology • Psoriasis

Efficacy, Safety, and Immunogenicity of SDZ-ADL, an Adalimumab Biosimilar, in Biologic-Naïve and Switched Patients with Immune-Mediated Inflammatory Diseases: A Literature Review. (PubMed, Adv Ther) - "Sandoz-adalimumab (SDZ-ADL; Hyrimoz®, GP2017) is an adalimumab (ADL) biosimilar approved for the treatment of immune-mediated inflammatory diseases...Real-world studies confirmed the effectiveness and safety of treatment initiation with SDZ-ADL and of switching to SDZ-ADL from ref-ADL or from other ADL biosimilars. This literature review provides evidence that SDZ-ADL is as effective and safe as ref-ADL in both biologic-naïve and biologic-experienced patients."

Clinical • Journal • Review • Ankylosing Spondylitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Experimental Medicine Studies of the Brain in Patients With Rheumatoid Arthritis REALISE (clinicaltrials.gov) - P=N/A | N=46 | Completed | Sponsor: NHS Greater Glasgow and Clyde | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

FREE: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease (clinicaltrials.gov) - P4 | N=148 | Enrolling by invitation | Sponsor: University Medical Center Groningen | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Persistence After Switching From Adalimumab Biosimilar MSB11022 to Adalimumab Biosimilar GP2017 in Patients With Chronic Inflammatory Rheumatic Diseases. (PubMed, J Pharm Technol) - "A total of 58 patients (92.1%) were biologic-naïve, and 27 (42.3%) received methotrexate. The retention rate at 12 months was 84%, with an adherence rate of 88.2%. Switching from adalimumab biosimilar MSB11022 to biosimilar GP2017 in patients with chronic inflammatory rheumatic diseases did not lead to signs of safety or loss of efficacy over 12 months other than those already known in the literature for the class of drugs."

Journal • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Biosimilars: enhancing treatment accessibility for patients with psoriasis (PsoriasisG2C 2024) - "Hyrimoz® (an adalimumab biosimilar) was approved by the Chilean Public Health Institute in August 2020 for moderate-to-severe plaque psoriasis...According to the literature, the observed response in patients was similar to that expected. The introduction of biosimilars in Chile represents an effective alternative that allows economic access to biologics in more patients with moderate–to-severe psoriasis who cannot receive other targeted therapies because of the cost."

Clinical • Cardiovascular • CNS Disorders • Dermatology • Dyslipidemia • Hypertension • Immunology • Infectious Disease • Inflammation • Mood Disorders • Pain • Psoriasis • Psychiatry

Perforating dermatosis in a young female patient receiving adalimumab biosimilar CTP-17 for chronic plaque psoriasis (PsoriasisG2C 2024) - "In particular, the patient affected by chronic plaque psoriasis and psoriatic arthritis had been successfully treated with adalimumab biosimilar GP2017 for 2 years, which was later switched to CTP17 for non-medical reasons. After ∼60 days the cutaneous lesions progressively improved, and the ulcers have been re-epithelized, with a residual post-inflammatory erythema. 49 Perforating dermatosis is usually associated with conditions such as trauma, diabetes, chronic renal failure and lymphoma, but is occasionally also triggered by drugs including biologics such as adalimumab, infliximab, etanercept and risankizumab."

Clinical • Chronic Kidney Disease • Dermatology • Diabetes • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Lymphoma • Metabolic Disorders • Mood Disorders • Oncology • Pain • Psoriasis • Psoriatic Arthritis • Renal Disease • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Tuberculosis

Advances in Adalimumab Biosimilar Usage in a Statewide Health System (AIBD 2024) - " A total of 22 IBD patients managed by a tertiary care center's specialty pharmacist were prescribed Adalimumab biosimilars, specifically Hadlima (ADA-BWWD), Amjevita (ADA-ATTO), Hyrimoz (ADA-ADAZ), and Yuflyma (ADA-AATY). Adalimumab biosimilars demonstrate comparable efficacy to the originator drug and are generally well-tolerated. The most common adverse effect is injection site reactions, potentially linked to the citrate-based formulation of the biosimilars. Laboratory values varied with disease severity and previous biologic failures."

Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • HLA-DQA1

Experimental Medicine Studies of the Brain in Patients With Rheumatoid Arthritis REALISE (clinicaltrials.gov) - P=N/A | N=46 | Active, not recruiting | Sponsor: NHS Greater Glasgow and Clyde | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Nov 2024 | Trial primary completion date: Jul 2024 ➔ Nov 2024

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Adalimumab Biosimilar-to-biosimilar Switch in Patients with Inflammatory Rheumatic Diseases – Real-world Evidence from the Nationwide Danish Registry, DANBIO (ACR Convergence 2024) - "Starting in January 2021, a biosimilar-to-biosimilar adalimumab switch from SB5 (Imraldi®) to GP2017 (Hyrimoz®) was performed in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA)...The analyses were adjusted for sex, baseline age, disease activity, patient global score on a VAS, disease duration, concomitant methotrexate, and previous ADAo history. Overall, 1233 patients (454 RA, 296 PsA, 483 axSpA) were included... This nationwide observational study describes stable treatment outcomes following a mandatory switch from the adalimumab biosimilar SB5 to GP2017 – with GP2017 one-year retention rates of nearly 90% and unaffected flare rates. The impact of adalimumab originator treatment history was minor. These results support the use of biosimilar adalimumab in routine care."

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