- |||||||||| Hulio (adalimumab-fkjp) / Fujifilm Kyowa Kirin Biologics, Biocon, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo, Hyrimoz (adalimumab-adaz) / Sandoz
Enrollment closed, Trial completion date, Trial primary completion date: Experimental Medicine Studies of the Brain in Patients With Rheumatoid Arthritis REALISE (clinicaltrials.gov) - Nov 18, 2024 P=N/A, N=46, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Nov 2024 | Trial primary completion date: Jul 2024 --> Nov 2024
- |||||||||| Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo, Eticovo (etanercept-ykro) / Biogen, Organon, Samsung, Ewopharma, Yuhan Corp, Mundipharma, Bionovis
PK/PD data, Journal: Population Pharmacokinetic Analysis and Simulation of Alternative Dosing Regimens for Biosimilars to Adalimumab and Etanercept in Patients with Rheumatoid Arthritis. (Pubmed Central) - Jun 27, 2024 A simulation of dosing the etanercept biosimilar at a lower rate of every 10 days reached steady-state concentrations earlier than the usual dosing rate of every 7 days. Simulations of altered dosing intervals could form the basis for future personalised dosing studies, potentially saving costs whilst increasing efficacy.
- |||||||||| leflunomide / Generic mfg.
Clinical, Retrospective data, Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-Effectiveness of Biosimilars vs Leflunomide in Patients With Rheumatoid Arthritis. (Pubmed Central) - Jun 26, 2024 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.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Humira (adalimumab) / AbbVie
Outcome of psoriasis patients switched from adalimumab originator to biosimilar: a retrospective, observational study () - Feb 20, 2024 - Abstract #AAD2024AAD_2896; 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.
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo, Eticovo (etanercept-ykro) / Biogen, Organon, Samsung, Ewopharma, Yuhan Corp, Mundipharma
Journal: Anti-tumor necrosis factor ?: originators versus biosimilars, comparison in clinical response assessment in a multicenter cohort of patients with inflammatory arthropathies. (Pubmed Central) - Dec 24, 2023 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.
- |||||||||| Enrollment status, Trial completion date, Trial primary completion date: FREE: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease (clinicaltrials.gov) - Nov 30, 2023
P4, N=148, Enrolling by invitation, Methods From July 2020 to September 2021, we proposed for consecutive and ambulatory IBD patients on maintenance Humira Recruiting --> Enrolling by invitation | Trial completion date: Jun 2023 --> Mar 2025 | Trial primary completion date: Jun 2023 --> Mar 2025
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Hukyndra (adalimumab biosimilar) / Cipla, Alvotech, Stada, Teva, JAMP Pharma, YAS Holding, Yuflyma (adalimumab-aaty) / Celltrion, Hikma
Review, Journal: Navigating adalimumab biosimilars: an expert opinion. (Pubmed Central) - Nov 3, 2023 No abstract available The patent expiry of Humira in 2018 opened up the current European market to eight adalimumab biosimilars - (in alphabetical order) Amgevita, Amsparity, Hulio, Hukyndra, Hyrimoz, Idacio, Imraldi
- |||||||||| Hulio (adalimumab-fkjp) / Fujifilm Kyowa Kirin Biologics, Biocon, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo, Hyrimoz (adalimumab-adaz) / Sandoz
Trial completion date, Trial primary completion date: Experimental Medicine Studies of the Brain in Patients With Rheumatoid Arthritis REALISE (clinicaltrials.gov) - Oct 31, 2023 P=N/A, N=50, Recruiting, The patent expiry of Humira in 2018 opened up the current European market to eight adalimumab biosimilars - (in alphabetical order) Amgevita, Amsparity, Hulio, Hukyndra, Hyrimoz, Idacio, Imraldi Trial completion date: Dec 2025 --> Jul 2024 | Trial primary completion date: Dec 2025 --> Jul 2024
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Review, Journal: TNF? inhibitor biosimilar associated with polychondritis. A case-based review. (Pubmed Central) - Jul 17, 2023 Severe SARS-CoV-2 infections in this cohort were rare.Optimization of BMI may contribute to reducing risk and severity of COVID-19 infection. 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
- |||||||||| Trial completion date, Trial initiation date, Trial primary completion date: CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (clinicaltrials.gov) - Apr 24, 2023
P=N/A, N=900, Not yet recruiting, As a result, switching patients, who are on remission maintenance therapy, should be viewed critically Trial completion date: Apr 2029 --> Jul 2029 | Initiation date: Apr 2023 --> Jul 2023 | Trial primary completion date: Apr 2028 --> Jul 2028
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo, Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp
Observational data, Journal: Effectiveness of non-medical switch from adalimumab bio-originator to SB5 biosimilar and from ABP501 adalimumab biosimilar to SB5 biosimilar in patients with chronic inflammatory arthropathies: a monocentric observational study. (Pubmed Central) - Mar 28, 2023 Our results provide a reassuring profile of effectiveness when switching from ADA originator to one of its biosimilars and between two different biosimilars. However, the worse outcome in PROs in patients initially treated with the bio-originator addresses the attention to a possible nocebo response, which should encourage comprehensive communication with patients.
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Trial completion: A Comparative Study Between ABP 501 and Humira (clinicaltrials.gov) - Jan 5, 2023 P3, N=425, Completed, As a result, switching patients, who are on remission maintenance therapy, should be viewed critically. Active, not recruiting --> Completed
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Humira (adalimumab) / Eisai, AbbVie
Adalimumab originator versus biosimilar adalimumab () - Oct 4, 2022 - Abstract #AGW2022AGW_465; Familiarity with these factors is imperative to allow individualized prescribing so that the choice of agent can be individualized to the needs of the patient, prescriber, and health care service. Targeted prescribing according to patients' needs may improve adherence, treatment success, and quality of life.
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