Solymbic (adalimumab biosimilar) / Amgen - 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

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

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

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

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

Cost-Effectiveness of Biosimilars vs Leflunomide in Patients With Rheumatoid Arthritis. (PubMed, JAMA Netw Open) - "The model assesses 3 competing treatment sequences initiated with biosimilar infliximab (CT-P13), biosimilar adalimumab (ABP-501), and leflunomide; all used in combination with methotrexate. In this economic evaluation study, the treatment sequences initiated with biosimilar DMARDs were cost-effective compared with the treatment sequence initiated with leflunomide in managing patients with RA who experienced failure with the initial methotrexate treatment. These results suggest the need to update clinical treatment guidelines for initiating biosimilars immediately after the failure of methotrexate for patients with RA."

Clinical • Cost effectiveness • HEOR • Journal • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • 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

Treatment Persistence and Switching Patterns of Adalimumab Biosimilar ABP 501 in European Patients with Rheumatologic Diseases. (PubMed, Rheumatol Ther) - "Across three rheumatologic diseases, about half of patients persisted on ABP 501 at the end of 12 months after treatment initiation in both Germany and France. Patients experienced with ADA were more likely to switch back to ADA RP, regardless of indication and country, suggesting a possible nocebo effect. Future studies are warranted to understand reasons of discontinuation and switching."

Journal • Ankylosing Spondylitis • Hematological Disorders • Immunology • Inflammatory Arthritis • Oncology • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Adalimumab Biosimilar in Pediatric Inflammatory Bowel Disease: A Retrospective Study from the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). (PubMed, Healthcare (Basel)) - "This is the first real-world study that particularly addresses the use of ADL-BioS in pediatric IBD. With high rates of treatment persistence and a low frequency of non-serious side effects, ADL-BioS seems to be effective."

Journal • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Pediatrics

Treatment persistence and switching patterns of ABP 501 in European patients with inflammatory bowel disease. (PubMed, Therap Adv Gastroenterol) - "About 50% of patients persisted on and were adherent to ABP 501 therapy during the first 12 months after treatment initiation in two large European countries. Post-ABP 501, switching patterns varied between countries, indicating diversified treatment practices warranting further research on reason(s) for switching and potential overall treatment outcomes."

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

Anti-tumor necrosis factor α: originators versus biosimilars, comparison in clinical response assessment in a multicenter cohort of patients with inflammatory arthropathies. (PubMed, Reumatismo) - "Real-life data demonstrated a similar safety profile between biosimilars and originators, but a reduced biosimilar retention rate at 24 months. Biosimilars could be considered a valid, safe, and less expensive alternative to originators, allowing access to treatments for a wider patient population."

Journal • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Oncology • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • TNFA

Pharmacokinetic and Safety Similarity of High- and Low-Concentration Formulations of Adalimumab Biosimilar ABP 501 (ACR Convergence 2023) - "Results of this study demonstrate PK similarity between ABP 501-HCF (100 mg/mL) and ABP 501-LCF (50 mg/mL) following a single SC injection in healthy adult subjects. Immunogenicity and safety of ABP 501-HCF and ABP 501-LCF were also found to be similar."

Clinical • PK/PD data • Oncology • Pain • TNFA

Real-World Experience of Adalimumab Biosimilar (ABP 501) Use in Patients with Inflammatory Bowel Disease in Europe. (PubMed, Adv Ther) - "Both patients with IBD and treating physicians reported high levels of satisfaction with ABP 501 among initiators and switchers."

Journal • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Early Intervention With Biosimilars Compared With Leflunomide in Established Rheumatoid Arthritis: A Cost-Effectiveness Analysis in Hong Kong (ISPOR-EU 2023) - "The model contains three competing treatments: biosimilar infliximab (CT-P13), biosimilar adalimumab (ABP-501), and leflunomide. Biosimilar DMARDs are likely to be the cost-effective alternatives to leflunomide in the management of patients with RA who failed initial methotrexate treatment in Hong Kong. Local reimbursement agencies should give full consideration to the early use of biosimilars given the fact that none of the reference bDMARDs are reimbursed at present."

Cost effectiveness • HEOR • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants (clinicaltrials.gov) - P1 | N=179 | Completed | Sponsor: Amgen

New P1 trial

Switching from adalimumab originator to biosimilar in patients with hidradenitis suppurativa results in losses of response – data from the German HS registry HSBest (WCD 2023) - "Our study showed that switching HS patients from adalimumab originator to biosimilar ABP 501 does significantly affect treatment effectiveness. As a result, switching patients, who are on remission maintenance therapy, should be viewed critically"

Clinical • Dermatology • Hidradenitis Suppurativa

A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=372 | Completed | Sponsor: Amgen

New P1 trial

TNFα inhibitor biosimilar associated with polychondritis. A case-based review. (PubMed, Rheumatol Int) - "This report presents a 43-year-old man with psoriatic arthritis treated with ABP-501 (Amgevita), an adalimumab (ADA) biosimilar and who developed RP, 8 months after the initiation of the treatment. This, is the first report of RP development during TNFα inhibitors biosimilar. We concluded that rheumatologists dealing with patients treated with TNFα inhibitors (originators or biosimilars), should be aware of several paradoxical reactions which may emerge and RP, is one of them."

Journal • Review • Dermatology • Immunology • Inflammatory Arthritis • Ocular Inflammation • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Cost per responder of adalimumab biosimilars versus methotrexate in patients with psoriasis: a real-life experience. (PubMed, J Dermatolog Treat) - "A cost-per responder analysis comparing adalimumab biosimilars MSB11022 (Idacio®) and ABP 501 (Amgevita) versus subcutaneous methotrexate was performed. The week 52 cost-effectiveness of Idacio is comparable to subcutaneous methotrexate. The lowering of the cost of biosimilar drugs makes them a more accessible therapeutic option and they also can be introduced earlier in the treatment of moderate-to-severe psoriasis."

Journal • Dermatology • Immunology • Psoriasis

ADALIMUMAB BIOSIMILAR IN PEDIATRIC INFLAMMATORY BOWEL DISEASE: REAL-WORLD DATA FROM AN INFLAMMATORY BOWEL DISEASE NETWORK (ESPGHAN 2023) - "Two (4.88%) patients underwent multiple switches (from ABP501 to GP2017). Treatment persistence with adalimumab biosimilar estimated according to the Kaplan-Meier method and table with the number of subjects at risk Conclusions To the best of our knowledge, this is the first real-world study specifically addressing the use of ADL-BioS in pediatric IBD. ADL-BioS appears to be effective in children with IBD, with high treatment persistence rates and a low incidence of non-serious adverse events."

Clinical • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis • CRP

Persistence on treatment and safety of TNF-alpha inhibitors biosimilars compared to originators: an observational study on the French National Health Data System (EULAR 2023) - "Since 2015, several biosimilar products have been marketed and reimbursed after the expiry of the originator patents of infliximab (IFX), etanercept (ETA) and adalimumab (ADA), reducing the cost of these treatments...After weighting, the hazard ratios (HR) and relative risks of treatment discontinuation or modification in biosimilar versus originator products were close to 1 or below 1, with confidence intervals covering 1, except for ADA ABP501 which showed a minor increased risk of non-persistence compared to ADA originator in inflammatory bowel diseases (HR 1.24 [1.09-1.41] and 1.22 [1.03-1.44] in CD and UC)...Conclusion Our study shows reassuring results regarding the persistence and safety of biosimilars compared to the originator anti-TNF alpha product in all licensed indications. Further studies need to be carried out to confirm these results, and to investigate the switch context."

Clinical • Observational data • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Oncology

Reduced response rates after changing the therapy of adalimumab-original to biosimilar Abp 501 in patients with Hidradenitis Suppurativa-Results from German Hidradenitis Suppurativa Register HSBEST (DDG-TAGUNG 2023) - No abstract available

Clinical • Dermatology • Hidradenitis Suppurativa

Treatment Persistence and Switching Patterns of Adalimumab Biosimilar ABP 501 (AMGEVITA®) in Patients with Psoriasis: An Observational Study Using German and French Pharmacy Claims Databases (AAD 2023) - "For both countries, most psoriasis patients initiating ABP501 persisted on treatment (switchers persisted longer). Patients switched to other AT most often switched to non-TNFi biologics in naïve patients and to RP in switchers. Reasons for switch rate are unknown."

Claims database • Clinical • Observational data • Dermatology • Immunology • Inflammation • Psoriasis