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

Late Development of Neurosarcoidosis on Adalimumab with Rapid Recurrence on a Biosimilar Agent (ACTRIMS Forum 2026) - "Ultimately, Amjevita was held, and he was treated acutely with pulse steroids followed by a long steroid taper...Most recently, he experienced recurrence of AS symptoms as was started on Upadacitinib, a JAK inhibitor... This case demonstrates that sarcoidosis can occur decades following the start of TNF⍺ therapy, much later than previously reported. Further, it supports the idea that rotation to a biosimilar molecule may be a trigger for paradoxical sarcoidosis in TNF⍺ therapy but also shows that rotation back to the original molecule may not be sufficient to avoid recurrence. Finally, it highlights the importance of exploration of other agents, including JAK inhibitors, for the treatment of NS when TNF⍺ inhibitors cannot be used."

Acute Kidney Injury • Ankylosing Spondylitis • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Metabolic Disorders • Nephrology • Renal Disease • Rheumatology • Sarcoidosis • Seronegative Spondyloarthropathies • Ulcerative Colitis

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

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

AMGEN TAKES ACTION WITH THE U.S. GOVERNMENT TO LOWER THE COST OF MEDICINES FOR AMERICAN PATIENTS (PRNewswire) - "The action satisfies the components outlined in President Trump's July 31 letter, including the Administration's Most Favored Nation pricing requests....Amgen will expand its direct-to-patient program, AmgenNow, to include Aimovig (erenumab-aooe) and Amjevita (adalimumab-atto). Both will be available at a discounted monthly price of $299, nearly 60% and 80% lower than their current U.S. list prices, respectively."

Commercial • Ankylosing Spondylitis • Crohn's disease • Idiopathic Arthritis • Migraine • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

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

Inflammation (Amgen Press Release) - "TEZSPIRE (tezepelumab-ekko) sales increased 40% year-over-year to $377 million in the third quarter...Otezla (apremilast) sales increased 4% year-over-year to $585 million in the third quarter...Enbrel (etanercept) sales decreased 30% year-over-year to $580 million in the third quarter, primarily driven by 38% lower net selling price resulting from the impact of the U.S. Medicare Part D redesign and increased 340B Program mix, partially offset by favorable changes to estimated sales deductions and volume growth; AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales decreased 7% year-over-year to $154 million in the third quarter...PAVBLU (aflibercept-ayyh) generated $213 million of sales in the third quarter; WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $44 million of sales in the third quarter."

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

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."

Clinical and out-of-pocket cost outcomes after switching to biosimilar adalimumab-atto in patients with rheumatoid arthritis. (PubMed, Expert Opin Biol Ther) - "The crude rates per 100 patient-years of the safety outcome and mean monthly changes in out-of-pocket costs were 5.6 (95% CI 4.2-7.5) and 7.2 (95% CI 5.2-9.2) (p = 0.21) and -$51 (±$164) and -$11 (±$152) (p < 0.01) in the Switcher and Non-Switcher groups, respectively. These results provide evidence that switching from RP adalimumab to biosimilar adalimumab-atto did not result in disease worsening or increased adverse events but did deliver modestly lower patient out-of-pocket costs."

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

AMGEN REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS (Amgen Press Release) - "AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales were flat year-over-year at $133 million in the second quarter. PAVBLU (aflibercept-ayyh) generated $130 million of sales in the second quarter. WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $35 million of sales in the second quarter."

Sales • Crohn's disease • Idiopathic Arthritis • Inflammatory Bowel Disease • Psoriatic Arthritis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Evaluation of Methods Employed in Establishing Preclinical Similarity of Adalimumab Biosimilars. (PubMed, Adv Pharmacol Pharm Sci) - "This review analyses published preclinical studies to assess the evaluation methods employed to establish biosimilarity between Humira and four key biosimilars: ABP501 (Amjevita), FKB327 (Hulio), MSB11022 (Idacio), and SB5 (Imraldi). Notably, while all four biosimilars demonstrated comparable functional properties to the reference product, variations in glycosylation patterns presented distinct regulatory challenges. This review is a valuable resource for biopharmaceutical scientists engaged in biosimilar development, ultimately supporting advancing more accessible and affordable treatment options while ensuring adherence to stringent efficacy, safety, and quality standards of adalimumab biosimilars."

Journal • Preclinical • Review • Immunology • Oncology • TNFA

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