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

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

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

Product Sales Performance (PRNewswire) - "TEZSPIRE (tezepelumab-ekko) sales increased 42% year-over-year to $486 million in the second quarter, driven by volume growth; Otezla (apremilast) sales decreased 21% year-over-year to $491 million in the second quarter, primarily driven by 9% lower net selling price and 6% lower volume; Enbrel (etanercept) sales decreased 4% year-over-year to $580 million in the second quarter...AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales increased 17% year-over-year to $155 million...."

Sales • Ankylosing Spondylitis • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Crohn's disease • Immunology • Plaque Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis

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

Association of Body Mass Index with SARS-CoV-2 Infection in Inflammatory Arthritis Patients Receiving Biologic Therapy: Singapore National Biologics Register Findings. (PubMed, Int J Rheum Dis) - "Being overweight or obese (BMI ≥ 23 kg/m2) was independently associated with higher COVID-19 infection risk. Severe infections were rare."

Journal • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Obesity • Oncology • Psoriatic Arthritis • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

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

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

Paradoxical Alopecia Areata Linked to Adalimumab-atto: case series (EADV-Sp 2026) - "Adalimumab-atto was discontinued, and topical clobetasol propionate 0.05% ointment was initiated...His disease was refractory to oral corticosteroids, cyclosporine, and acitretin but achieved control for 43 weeks with ustekinumab, which was discontinued due to financial constraints...Adalimumab-atto was continued with close monitoring, cyclosporine was tapered and discontinued, and topical therapy for alopecia with alternating mometasone furoate lotion and tacrolimus 0.1% ointment was started...Examination of the palms reveals diffuse, symmetric, yellow-orange waxy hyperkeratosis with accentuated skin markings, consistent with palmoplantar involvement of pityriasis rubra pilaris, and the trunk and neck demonstrate controlled pityriasis rubra pilaris at the time of alopecia onset. Results N/A Conclusions - Borderline paradoxical alopecia areata is a rare but clinically significant immune-mediated adverse effect of TNF-α inhibitors, including the biosimilar adalimumab-atto..."

Clinical • Alopecia • Endocrine Disorders • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Inflammatory Arthritis • Plaque Psoriasis • Psoriasis • Psoriatic Arthritis • Seronegative Spondyloarthropathies • Thrombocytopenia • Thrombocytopenic Purpura • Vitiligo

Product Sales Performance (Amgen Press Release) - "Enbrel (etanercept) sales decreased 37% year-over-year to $320 million...AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales increased 27% year-over-year to $173 million....PAVBLU (aflibercept-ayyh) generated $280 million in the first quarter."

Sales • Ankylosing Spondylitis • Crohn's disease • Hidradenitis Suppurativa • Idiopathic Arthritis • Plaque Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

PBAC Recommends PBS Reimbursement for Biosimilars to Adalimumab (High Concentration), Omalizumab (PFP) & Ustekinumab (Pearce IP) - "At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement of the following biosimilars: Amgen’s Amgevita (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP); Celltrion’s Yuflyma (adalimumab) in 20mg/0.2ml PFS; Celltrion’s Omlyclo (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP; Sandoz’s Ardelya (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS; Amgen’s Wezlana (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS and 130 mg in 26 mL solution for IV infusion."

Reimbursement • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Crohn's disease • Hidradenitis Suppurativa • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Characteristics and safety outcomes of rheumatoid arthritis patients treated with AMGEVITA® in the United Kingdom using data from a national register. (PubMed, Arthritis Res Ther) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Comparative Study Assessing Multiple Switches Between Biosimilar ABP 501 (adalimumab-atto) and Adalimumab Reference Product in Patients with Plaque Psoriasis. (PubMed, Adv Ther) - P3 | "This study demonstrates PK similarity in patients with plaque psoriasis who underwent three treatment switches between adalimumab RP and ABP 501 as compared with those who received continuous treatment with adalimumab RP. Safety, immunogenicity, and efficacy profiles were comparable. Overall, results support the interchangeability designation of ABP 501 with adalimumab RP, consistent with the US Food and Drug Administration (2019) guidelines."

Clinical • Journal • Dermatology • Immunology • Psoriasis

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

Preventing Structural Damage in Early Psoriatic Arthritis (clinicaltrials.gov) - P4 | N=108 | Recruiting | Sponsor: Chinese University of Hong Kong

New P4 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Meds from Amgen…now offered through TrumpRx DTC platform (Fierce Pharma) - "Amgen’s Humira biosimilar Amjevita, migraine med Aimovig and cholesterol drug Repatha became available through TrumpRx on Monday....Amjevita can be purchased by cash-paying patients for $299 per month, an 80% discount to the med’s list price of $1,484. Aimovig and Repatha are discounted by 62% off their respective list prices, according to the website."

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

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

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

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."