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

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

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

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

Samsung Bioepis’ Fourth Quarter 2024 US Biosimilar Market Report Highlights Challenges and Strategies for Biosimilar Adoption (GlobeNewswire) - "Samsung Bioepis Co., Ltd. today released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States....As of Aug 2024, adalimumab biosimilar market share has reached 22%, rising 4% since May 2024, highly driven by the uptake of biosimilars through private label brands."

Commercial • Ankylosing Spondylitis • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Real-World Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the PERFUSE Study. (PubMed, Drugs Real World Outcomes) - P=N/A | "SB5 provides clinically effective treatment of both gastrointestinal and rheumatic IMIDs for naïve and switched patients, with no loss of control observed when switching. Persistence was comparable between naïve and switched populations, though the reasons for non-persistence differed."

Clinical data • HEOR • Journal • Real-world • Real-world evidence • Ankylosing Spondylitis • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • CRP

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

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

A randomised, crossover trial exploring the patient perspective and effectiveness of biosimilar adalimumab transition: IBD reference and biosimilar adalimumab cross over study (iBaSS). (PubMed, Int J Clin Pharm) - P4 | "This study, mimicking real world adalimumab transition, demonstrates that patients undertaking brand transition can be expected to have consistent clinical and satisfaction outcomes."

Journal • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Pain

Understanding Pharmacy Benefit Manager (PBM) Adoption of Humira Biosimilars and Identifying Their Preferred Humira Biosimilars in Comparison with Humira (ISPOR 2024) - "As of the review conducted on January 4, 2024, Hadlima was covered by 4 PBMs while Hyrimoz (both brand and generic) was covered by 3 PBMs. Despite the introduction of branded equivalent biosimilars in the US market at discounted costs compared with Humira, PBMs uptake remains limited. This low adoption by PBMs may potentially limit prescribing patterns and clinical uptake of Humira biosimilars if formularies."

Anesthesia • Hematological Disorders • Immunology • Musculoskeletal Diseases • Orthopedics • Osteoarthritis • Osteoporosis • Rheumatology

Early Real-World Experience With Abrilada Within the Canadian Patient Population (ISPOR 2024) - "Results were compared to the reference adalimumab (D2E7, “ADL-Ref”) and other adalimumab biosimilars (ABP501, SB5, FKB327, GP2017, MSB11022, AVT02 and CT-P17) This retrospective cohort study utilized longitudinal claims data from IQVIA Canada’s Private Drug Plan and Ontario Drug Benefit databases... Our findings suggest high persistence and adherence rates for patients receiving adalimumab-afzb in a real-world setting. Further studies are needed to determine the persistence and adherence of adalimumab biosimilars over an extended duration."

Clinical • Real-world • Real-world evidence • Anesthesia • Hematological Disorders • Immunology • Pain

Adalimumab-bwwd, a biosimilar of adalimumab, has the potential for substantial cost savings when prescribed (AMCP 2024) - "In a scenario based on publicly available pricing, substantial cost savings were generated from switching patients to adalimumab-bwwd. As confirmed by real-world experience of other biosimilar adoption in the United States, the magnitude of these savings is dif- ficult to predict because of invisible rebate structures but adoption of biosimilars would inevitably realize substan- tial savings to plans."

HEOR • Immunology • Musculoskeletal Diseases • Osteoarthritis • Osteoporosis • Pain • Rheumatoid Arthritis • Rheumatology

Support Programme for Patients Receiving Imraldi or Benepali Therapy for Immune-Mediated Inflammatory Disorders: 12-Month Persistence (BSR 2024) - "Compared to the non-PSP cohort, patients enrolled in the PSP had higher persistence at 12 months after initiation, across all indications and regardless of prior biologic exposure. This real-world evidence indicates the benefits of a PSP to patients with chronic diseases, and that particular attention should be paid to biologic-naïve patients."

Clinical • Dermatology • Gastroenterology • Inflammation • Rheumatology

Outcome of psoriasis patients switched from adalimumab originator to biosimilar: a retrospective, observational study (AAD 2024) - "Background As a cost saving measure, psoriasis patients established on adalimumab originator (Humira) were switched to adalimumab biosimilar, Imraldi...31 patients were switched back to originator/alternative biosimilar (Amgevita)...Patients who successfully switched back to the originator, did not re-achieve the same disease control as before switching. Factors associated with switching failure included: male sex, higher weight, high-impact sites involvement and presence of concomitant PsA."

Observational data • Retrospective data • Dermatology • Immunology • Inflammatory Arthritis • Pain • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Interchangeability of SB5 and Adalimumab Reference Product in Patients with Moderate to Severe Chronic Plaque Psoriasis (AAD 2024) - "Multiple switches between SB5 and RP have equivalent PK, with comparable efficacy, safety, and immunogenicity to continuation of RP."

Clinical • Dermatology • Immunology • Psoriasis

Prospective evaluation of the switch from adalimumab originator to different biosimilars in IBD patients : acceptability and persistance at 1 year. (ECCO-IBD 2024) - "Methods From July 2020 to September 2021, we proposed for consecutive and ambulatory IBD patients on maintenance Humira® to switch to one of the five ADA biosimilars available at the time of the study (Amgevita®, Idacio®, Imraldi®, Hulio®, Hyrimoz®) at Lille University Hospital (France). Conclusion A large proportion of IBD patients (91.8%) accepted the switch from ADA originator to a biosimilar and 60% continued ADA biosimilar at 1 year. The high acceptability of the switch encourages the use of ADA biosimilars in clinical practice."

Clinical • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis