Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo, Orion Corp - LARVOL DELTA

Product Sales Performance (PRNewswire) - "Otezla (apremilast) sales increased 11% year-over-year to $437 million in the first quarter, driven by 12% favorable changes to estimated sales deductions, as volume growth of 4% was offset by 5% lower net selling price; Enbrel (etanercept) sales decreased 10% year-over-year to $510 million in the first quarter, driven by 47% lower net selling price resulting from increased 340B Program mix and higher commercial discounts, partially offset by 19% favorable changes to estimated sales deductions, higher inventory levels and volume growth...AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales decreased 19% year-over-year to $136 million in the first quarter, primarily driven by 33% lower net selling price, partially offset by 11% volume growth; WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $150 million of sales in the first quarter. WEZLANA launched in the U.S. in the first quarter of 2025....PAVBLU (aflibercept-ayyh) generated $99 million of sales in the first quarter."

Sales • Age-related Macular Degeneration • Ankylosing Spondylitis • Crohn's disease • Diabetic Macular Edema • Diabetic Retinopathy • Idiopathic Arthritis • Psoriasis • Psoriatic Arthritis • Retinal Vein Occlusion • Rheumatoid Arthritis • Ulcerative Colitis

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

A single-centre analysis of a biosimilar switching programme for adalimumab in inflammatory bowel disease. (PubMed, Br J Clin Pharmacol) - "Switching to biosimilar adalimumab did not affect disease control or quality of life. 25% of patients developed new side effects, particularly those with high levels of health anxiety. Significant cost savings were achieved."

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

Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians. (PubMed, BioDrugs) - "A search of the MEDLINE database was used to identify publications on switching to and among adalimumab biosimilars in an ex-US setting, with no restriction on publication language and using a time frame of 1 January 2017 through 12 December 2023, coinciding with the European Union approval of the first adalimumab biosimilar, adalimumab-atto, in March 2017...Overall, RWE suggested that efficacy and outcomes were consistent in patients who underwent switching from the reference product (RP) across various immune-mediated inflammatory diseases when compared to patients who did not switch from the RP. The ex-US RWE of RP and biosimilar adalimumab switches generally reflected the experiences observed in clinical trials; however, RWE findings elucidated several challenges to biosimilar uptake, including patient education, provider training, and supportive policies."

Journal • Review • Inflammation

Perceptions of patients with inflammatory bowel diseases on switching from reference product adalimumab to biosimilar adalimumab-atto. (PubMed, Expert Opin Biol Ther) - "There was widespread satisfaction with adalimumab-atto after switching from RP adalimumab. Nevertheless, participants reported limited knowledge of adalimumab-atto, suggesting a need for enhanced education on biosimilars."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

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

Nonmedical switch of anti-TNF-α biosimilars has no major clinical, pharmacokinetic and psychological impact on patients with IBD - the SAFER Study. (PubMed, Dig Liver Dis) - "Nonmedical switch of infliximab and adalimumab biosimilars does not significantly affect treatment effectiveness, safety and pharmacokinetics, nor does it have major psychological implications for patients."

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

Real-World Experience with an Adalimumab Biosimilar (ABP 501) in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis in Europe: Results from the Adelphi Disease Specific Programme. (PubMed, Rheumatol Ther) - "Across indications, both physicians and patients reported positive clinical outcomes and high levels of satisfaction with ABP 501 treatment, regardless of prior use of RP."

Journal • Real-world evidence • Ankylosing Spondylitis • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Effectiveness of Adalimumab Biosimilars and Originator for Psoriasis. (PubMed, JAMA Dermatol) - "Patients who switched to Amjevita and Imraldi also had no statistically significant differences in achieving a PASI score of 2 or less (Amjevita: aOR, 1.19; 95% CI, 0.94-1.51; Imraldi: aOR, 0.92; 95% CI, 0.72-1.18) and a PASI score of 4 or less (Amjevita: aOR, 1.32; 95% CI, 0.96-1.84; Imraldi: aOR, 1.00; 95% CI, 0.70-1.41) compared with those who continued Humira. In this study, Amjevita and Imraldi were as effective as Humira for both new starters and patients switching to biosimilars from Humira."

Journal • Dermatology • Immunology • Psoriasis

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS (PRNewswire) - "TEZSPIRE (tezepelumab-ekko) sales increased 67% year-over-year to $296 million in the fourth quarter and 71% for the full year, primarily driven by volume growth. Otezla (apremilast) sales decreased 1% year-over-year to $624 million in the fourth quarter, driven by 7% lower net selling price, partially offset by 5% volume growth. Sales decreased 3% for the full year, primarily driven by 8% lower net selling price, partially offset by 3% volume growth. Enbrel (etanercept) sales were flat year-over-year at $1.0 billion in the fourth quarter as 7% favorable changes to estimated sales deductions were offset by lower net selling price. Full year sales decreased 10%, driven by lower net selling price. For 2025, we expect continued declining net selling price and relatively flat volumes. AMJEVITA/AMGEVITA (adalimumab) sales increased 84% year-over-year to $294 million in the fourth quarter and 22% for the full year, driven by volume growth, partially offset by lower net selling price."

Sales • Asthma

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

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

Consequences of Switching Originator Biological Therapies to Its Biosimilars in Patients with Immune-mediated Diseases in a Mexican Cohort (ACR Convergence 2024) - "Patients who were switched from an originator biological to its biosimilar were followed up every 3 months; biological therapies included were: Adalimumab (ADA), Rituximab (RTX) and Etanercept (ETN), with their biosimilars Amgevita, Maball and Infinitam, respectively. Switching of originator biological therapies to its biosimilar in our cohort of patients might not have an impact on efficacy or the incidence of infections; however, one of the most common AEs was associated with the mechanics of the autoinjector device. Although this may seem a minor issue, it led to patients missing a dose, thus having an impact on treatment compliance and thus the activity of the disease."

Clinical • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Musculoskeletal Pain • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Systemic Lupus Erythematosus

AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS (PRNewswire) - "Repatha (evolocumab) sales increased 40% year-over-year to $567 million in the third quarter, driven by 41% volume growth and 8% favorable changes to estimated sales deductions, partially offset by 10% lower net selling price....AMJEVITA/AMGEVITA (adalimumab) sales increased 9% year-over-year to $166 million in the third quarter....TEPEZZA (teprotumumab-trbw) generated $488 million of sales in the third quarter. TEPEZZA is the first and only FDA-approved treatment for thyroid eye disease (TED)....UPLIZNA (inebilizumab-cdon) generated $106 million of sales in the third quarter. UPLIZNA is used to treat adults with neuromyelitis optica spectrum disorder."

Sales • Cardiovascular • Crohn's disease • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia • Homozygous Familial Hypercholesterolemia • Immunology • Inflammatory Bowel Disease • Ophthalmology • Scleroderma • Systemic Sclerosis • Thyroid Eye Disease • Ulcerative Colitis

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

Very Low Uptake of Biosimilar Adalimumab in the First 9 Months of Availability in Rheumatology (ACR Convergence 2024) - "70.4% (n=181) of biosimilar prescriptions were adalimumab-atto, which was the first released. We found critically low uptake of biosimilar adalimumab in the first nine months of 2023. Early indications are that formulary coverage has been uneven with a much higher percentage of formularies covering bio-originator adalimumab and no formularies have given a biosimilar a preferential tier or mandated step therapy. Delayed uptake of biosimilars means reduced savings for patients and tax payers, and discourages market entry for future biosimilars."

Rheumatology

Therapeutic Drug Monitoring of the Adalimumab Biosimilar (AMJEVITA™, Adalimumab-atto) Using Originator Adalimumab and Anti-Adalimumab Antibody Assays (ACR Convergence 2024) - "This study demonstrates complete cross-reactivity of biosimilar adalimumab-atto and originator adalimumab using the originator ADL drug and anti-drug antibody assays. Analytical performance of all tested parameters demonstrated equivalency. Therefore, clinicians can confidently use the originator ADL tests to monitor drug levels and ADA titers in patients on the biosimilar adalimumab-atto."

Experience with multiple non-medical switches between originator and biosimilars of adalimumab in patients with psoriasis (EADV 2024) - "At our department, there have been three mandatory non-medical switches: from the originator to GP2017 to ABP 501 to GP2017. The findings indicate that multiple non-medical switches between originator and biosimilar adalimumab are safe and without loss of effectiveness among patients with psoriasis. FIGURE 1. Survival plot visualising the number of patients within each subcohort at different time points."

Clinical • Dermatology • Immunology • Psoriasis

Comparative Study Assessing Multiple Switches Between Biosimilar ABP 501 and Adalimumab Reference Product in Patients with Plaque Psoriasis (EADV 2024) - "Results of this study demonstrated similarity for PK, efficacy, immunogenicity, and safety in patients with Ps switching 3 times between adalimumab RP and ABP 501 as compared to patients receiving continued use of adalimumab RP. These results support a demonstration of interchangeability between ABP 501 and adalimumab RP."

Clinical • Ankylosing Spondylitis • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hidradenitis Suppurativa • Idiopathic Arthritis • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Ocular Inflammation • Ophthalmology • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • Uveitis

Effectiveness of Switching From Reference Adalimumab to Biosimilar Adalimumab-Atto in Patients With Uveitis (AAO 2024) - "Two percent and 1.6% of patients switched to a different biologic or back to adalimumab, respectively. Conclusion Adalimumab-atto is noninferior to adalimumab in the treatment of uveitis, with a low failure rate."

Clinical • Ocular Inflammation • Ophthalmology • Uveitis

Adalimumab originator and biosimilars in global inflammatory bowel disease treatment (AGW-GESA 2024) - "Products marketed in Australia, namely Humira, Yuflyma, Idacio, Hyrimoz, Hadlima, Abrilada, and Amgevita, as well as Exemptia in India, provide the most extensive support. Adalimumab products exhibit variations in formulations and associated support programs across different countries. Among the four products offering high-concentration citrate-free formulations, Humira and Xelenka offer a wide range of dosages for different indications. Meanwhile, Xelenka, Yuflyma, and Ardalicip provide the longest room temperature shelf lives, which is favourable for travellers."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics

A Bayesian model to analyse the association of comorbidities with biosimilar treatment retention in a non-medical switch scenario in patients with inflammatory rheumatic musculoskeletal diseases. (PubMed, Arthritis Res Ther) - "In a non-medical switch scenario of RMD patients, there was no evidence for a considerable difference in ABP retention rates over 6 months between comorbidity groups."

Journal • Ankylosing Spondylitis • Cardiovascular • Dermatology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Patient preferences for adalimumab in inflammatory bowel disease: a nationwide study from the GETAID. (PubMed, Therap Adv Gastroenterol) - "The most commonly used drugs at inclusion were Humira® (436/941, 46.3%), Amgevita® (177/941, 18.8%) and Hulio® (105/941, 11.2%)...Satisfaction with the subcutaneous injection form was higher for patients treated with Yuflyma® (9.0 (1.4)), Humira (8.9 (1.3)) and Hulio (8.9 (1.7)) (p < 0.05)...In all, 223 patients (23.7%) reported being previously treated with another adalimumab of which (32/223, 14.3%) discontinued treatment due to side effects. In this real-world setting, patients with IBD had a high level of satisfaction with adalimumab treatment, with some differences in terms of overall satisfaction and satisfaction with the injection device."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

The effectiveness of adalimumab biosimilars and originator for the treatment of psoriasis: a cohort study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) (BAD 2024) - "Switching to Amgevita® and Imraldi® from Humira® did not change treatment effectiveness significantly. The study is funded by the Psoriasis Association and supported by the NIHR Manchester Biomedical Research Centre (NIHR203308)."

Immunomodulating • Dermatology • Immunology • Psoriasis