Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, AbbVie, Mundipharma, Yuhan Corp - LARVOL DELTA

Real World Evidence From the US Veterans Affairs Healthcare System of a Successful Switch to Biosimilar adalimumab-bwwd (Hadlima) from Originator adalimumab (Humira) Following a Formulary Change (ACR Convergence 2026) - No abstract available

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

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

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

Poster data at KCR 2026 highlight patient-reported gains and consistent safety for Adalloce (Chosun Biz) - “First, in an observational study of 488 patients with rheumatoid arthritis and ankylosing spondylitis, the health-related quality-of-life index (EQ-5D-5L) improved by an average of 0.09 points after 52 weeks of Adalloce administration…also announced PMS results of 303 patients across all approved indications for Adalloce. The incidence of adverse events was 29.7%, and the incidence of serious adverse events was 2.6%, which the company said was similar to safety results observed in prior clinical trials.”

Clinical data • Ankylosing Spondylitis • Rheumatoid Arthritis

PATIENT CHARACTERISTICS AND UTILIZATION OF ADALIMUMAB-BWWD IN THE US DEPARTMENT OF VETERANS AFFAIRS POPULATION (ISPOR 2026) - "Transitioning patients from higher-cost reference adalimumab to biosimilar adalimumab-bwwd was demonstrated to be feasible within the VHA system and associated with favorable adherence rates."

Clinical • Cardiovascular • CNS Disorders • Depression • Diabetes • Dyslipidemia • Hypertension • Metabolic Disorders • Type 2 Diabetes Mellitus

Samsung Bioepis Releases Second Quarter 2026 US Biosimilar Market Report (Businesswire) - "Adalimumab and ustekinumab biosimilars are gaining traction, with market shares reaching 60% and 27%, respectively...As of the second quarter of 2026, the average ASP of ustekinumab biosimilars had declined to $753, representing a 73% decrease from the previous quarter. This sharp decline was primarily attributable to revisions in ASP calculations for several ustekinumab biosimilars, which were adjusted to reflect only the price of the initial intravenous loading dose which falls under Medicare Part B....The two eculizumab biosimilars — Bkemv and Epysqli — are respectively discounted 9% and 32% below the reference product’s ASP, reflecting divergent pricing strategies."

Sales • Ankylosing Spondylitis • Atypical Hemolytic Uremic Syndrome • Crohn's disease • Hidradenitis Suppurativa • Idiopathic Arthritis • Immunology • Myasthenia Gravis • Paroxysmal Nocturnal Hemoglobinuria • Plaque Psoriasis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • 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

Patient Outcomes at the Veterans Affairs Ann Arbor Healthcare System (VAAAHS) from VA Formulary Switch from Adalimumab to Adalimumab-bwwd (ASHP 2025) - No abstract available

Clinical

Efficacy and Safety of Switching from Adalimumab Originator to SB5 Biosimilar in Noninfectious Uveitis: Early Clinical Outcomes. (PubMed, J Clin Med) - "Background/Objectives: To evaluate the real-world efficacy and safety of switching from adalimumab originator (Humira®, AbbVie) to SB5 biosimilar (Adalloce®, Samsung Bioepis) in patients with noninfectious uveitis...No other adverse events were observed. Switching from adalimumab originator to SB5 biosimilar maintained clinical stability with comparable efficacy and safety in patients with noninfectious uveitis, supporting its use as a cost-effective alternative."

Clinical data • Journal • Ocular Inflammation • Ophthalmology • Uveitis

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

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

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

US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon HADLIMA (adalimumab-bwwd) Injection (Yahoo Finance) - "Samsung Bioepis Co., Ltd. and Organon & Co....announced that the US Food and Drug Administration (FDA) has designated the HADLIMA (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira (adalimumab)....With today’s additional interchangeability designations, HADLIMA is now interchangeable with all presentations of the reference product....The interchangeability designation was based on clinical data from a randomized, double-blind, 1:1 ratio, parallel-group, multiple-dose clinical trial, which assessed pharmacokinetics (PK), efficacy, safety, and immunogenicity in two treatment groups: patients with moderate to severe plaque psoriasis who switched between formulations of EU-sourced Humira and high-concentration SB5 (adalimumab biosimilar) versus patients receiving Humira continuously."

FDA approval • Immunology • Psoriasis

Challenging the Paradigm: Severe Rheumatoid Arthritis and Anti-TNF Failure in an X-Linked Agammaglobulinemia Patient (CIS 2025) - "Case Presentation: We report a case of a 56-year-old male with XLA, diagnosed at age 5, and chronic seronegative erosive polyarthritis who failed anti-TNF therapy with adalimumab (Hadlima), despite the absence of circulating B cells...After treatment failure with adalimumab, he was switched to upadacitinib (JAK1 inhibitor) with significant improvement and resolution of his synovitis... This case raises questions about the mechanisms underlying treatment resistance in B cell–deficient patients and highlights a rare and complex presentation of autoimmune RA and anti-TNF treatment failure in a patient with XLA. These findings underline the need for further investigation into immune dysregulation in XLA and the implications for autoimmune disease development and treatment response [3]."

Clinical • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Primary Immunodeficiency • Rheumatoid Arthritis • Rheumatology • BTK

IMKASID 2025: Study Shows Ustekinumab Biosimilars Could Save €526 Million Across European Markets (Firstwordpharma Press Release) - "The study aimed to assess the safety and effectiveness of adalimumab biosimilar (SB5) in clinical practice for the approved indications of axial spondyloarthritis (axSpA), rheumatoid arthritis (RA), PsA, PsO, Ulcerative colitis (UC), CD, etc. in Korea...238 patients (99 with axSpA, 129 with RA, 7 with CD, 2 with UC and 1 PsA) were enrolled and were monitored from September 2017 to June 2024....It was concluded that SB5 was effective in Korean patients with axSpA, RA, CD, UC and PsA in real world setting without any new safety signal, which were consistent with those observed in the previous clinical studies."

Real-world effectiveness • Ankylosing Spondylitis • Crohn's disease • Immunology • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

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

Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2024 (GlobeNewswire) - "Biosimilars revenue increased 12% on both an as-reported and ex-FX basis for full year 2024, compared with the prior year, primarily driven by growth in Hadlima, following its U.S. launch in July 2023. Renflexis and Ontruzant declined 1% ex-FX and 9% ex-FX, respectively, as both products are in the mature phase of their product life cycles and face significant competitive pricing pressure. Established Brands revenue grew 2% both on an as-reported basis and ex-FX in the fourth quarter of 2024, primarily related to the revenue contribution of Emgality (galcanezumab-gnlm) and Vtama (tapinarof), which together more than offset the impact of the loss of exclusivity ('LOE') of Atozet (ezetimibe and atorvastatin) in key markets in Europe and in Japan."

Commercial • Ankylosing Spondylitis • Atherosclerosis • Atopic Dermatitis • Breast Cancer • Crohn's disease • Dyslipidemia • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer • Migraine • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Comparing adalimumab biosimilars in the clinical practice of psoriatic patients. (PubMed, Ital J Dermatol Venerol) - "The findings of this study support the efficacy and safety of Idacio and Imraldi in managing psoriasis, with Idacio demonstrating superior efficacy in reducing disease severity. Future studies could benefit from expanding the patient cohort and conducting further analyses to evaluate individual responses to treatment."

Clinical • Journal • Dermatology • Immunology • Inflammation • Pruritus • Psoriasis • TNFA

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

Long-term real-world evidence of SB5 (adalimumab biosimilar) treatment in patients with moderate-to-severe psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR). (PubMed, J Dermatolog Treat) - "SB5 (adalimumab-bwwd) is an adalimumab biosimilar targeting tumor necrosis factor (TNF) for the treatment of chronic inflammatory diseases, including moderate-to-severe chronic plaque psoriasis...Median persistence of SB5 in predominantly bio-naïve psoriasis patients was about 2.5 years in clinical practice. The results suggest that SB5 can be confidently used for patients with psoriasis, offering comparable outcomes to reference adalimumab."

HEOR • Immunomodulating • Journal • Observational data • Real-world • Real-world evidence • Dermatology • Immunology • Oncology • Psoriasis • TNFA

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

Possibilities and Limitations in Substituting anti-Drug Antibody Titers with Signal-to-Noise Ratios: A Comprehensive Comparison Using Two Clinical Trial Datasets of Adalimumab. (PubMed, AAPS J) - "Nonetheless, sub-analyses with time or adalimumab level showed a change in the regression between S/N ratios and titers, leading to different titer values from the same S/N ratio. These data demonstrate that S/N ratios may fully replace titers in limited circumstances such as a biosimilar study which goal is to prove equivalence between the originator and candidate product, but need a caution in other cases."

Journal • Dermatology • Immunology • Psoriasis