Solymbic (adalimumab biosimilar) / Amgen 
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  • ||||||||||  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.
  • ||||||||||  Abrilada (adalimumab-afzb) / Pfizer
    Early Real-World Experience With Abrilada Within the Canadian Patient Population () -  Mar 8, 2024 - Abstract #ISPOR2024ISPOR_2169;    
    These results suggest the need to update clinical treatment guidelines for initiating biosimilars immediately after the failure of methotrexate for patients with RA. Results were compared to the reference adalimumab (D2E7,
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
    Pharmacokinetic and Safety Similarity of High- and Low-Concentration Formulations of Adalimumab Biosimilar ABP 501 (Poster Hall; in person) -  Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_4133;    
    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.
  • ||||||||||  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   
    Immunogenicity and safety of ABP 501-HCF and ABP 501-LCF were also found to be similar. 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
  • ||||||||||  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
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo, Humira (adalimumab) / Eisai, AbbVie
    Treatment Persistence and Switching Patterns of ABP 501 (AMGEVITA®) in German Patients with Rheumatic Diseases (Virtual Poster Hall) -  Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_3253;    
    Thus, differences in baseline medication use and available treatment options for each indication should be considered when interpreting persistence and switching pattern data. Further studies are necessary to better understand the reasons for these differences in switching patterns
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo, Humira (adalimumab) / Eisai, AbbVie
    Real-World Utilization of Adalimumab Biosimilar (ABP 501) in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis in Europe (Virtual Poster Hall) -  Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_1093;    
    The most frequently reported reasons for switch from RP to ABP 501 were financial and formulary driven reasons.Figure 1: Top 3 reasons for switch from RP to ABP 501 reported by physicians for (a) RA Switchers (n=63), (b) AS Switchers (n=80), (c) PsA Switchers (n=173). Reported for switcher groups from multiple choice answer options that varied between indications and were not mutually exclusive.Table 1: Demographics, clinical characteristics and PROMs for patients receiving ABP 501 across indications
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
    Enrollment closed:  A Comparative Study Between ABP 501 and Humira (clinicaltrials.gov) -  May 18, 2022   
    P3,  N=425, Active, not recruiting, 
    This real-life study confirms the similar efficacy profile of multiple switch bsADA with long-term retention and a good safety profile in inflammatory arthritis patients. Recruiting --> Active, not recruiting
  • ||||||||||  Hadlima (adalimumab biosimilar) / Organon, Merck (MSD), Biogen, Samsung, Mundipharma
    Journal:  Real-Life Effectiveness of Adalimumab Biosimilars in Patients with Chronic Plaque Psoriasis. (Pubmed Central) -  Apr 28, 2022   
    No difference in efficacy and safety was found between ADA biosimilars. The real-life effectiveness of adalimumab biosimilars in patients with psoriasis is consistent with that previously reported for the originator.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
    Retrospective data, Journal:  Establishing PK Equivalence Between Adalimumab and ABP 501 in the Presence of Antidrug Antibodies Using Population PK Modeling. (Pubmed Central) -  Apr 21, 2022   
    A traditional approach for evaluating bioequivalence based on noncompartmental analysis may be inappropriate for drugs with a high incidence of ADAs because accounting for the effect of ADAs on noncompartmental analysis parameters is challenging. Use of a population PK model to discern the effect of ADAs on drug PK variables allows for assessment of PK similarity accounting for the presence or absence of ADAs.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
    Trial completion date, Trial primary completion date:  A Comparative Study Between ABP 501 and Humira (clinicaltrials.gov) -  Feb 20, 2022   
    P3,  N=414, Recruiting, 
    LISA-TRACKER ADA and anti-ADA assays are reliable for the monitoring of patients treated with ABP501. Trial completion date: Oct 2023 --> Feb 2023 | Trial primary completion date: Oct 2023 --> Feb 2023
  • ||||||||||  Yuflyma (adalimumab biosimilar) / Pfizer, Celltrion, Nippon Kayaku
    Review, Journal:  An Update Review of Biosimilars of Adalimumab in Psoriasis - Bioequivalence and Interchangeability. (Pubmed Central) -  Jan 1, 2022   
    This review discusses the bioequivalence of adalimumab biosimilars as demonstrated by various clinical trials, the extrapolation of indications, guidance and policies of the EU and US on interchangeability (nonmedical switching/automatic substitution) between biosimilars and originators, and the real-life practices of switching from reference adalimumab to the respective biosimilars. Further data from real-world studies and post-marketing analyses are needed better to address the efficacy and safety of the transition strategy.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
    Trial completion date, Trial primary completion date:  A Comparative Study Between ABP 501 and Humira (clinicaltrials.gov) -  Nov 18, 2021   
    P3,  N=414, Recruiting, 
    Moreover, comparable results were obtained with the WHO IS, and thus, demonstrate that Promonitor Quick tests are suited to accurately determine drug levels at the clinical decision points in both whole blood and serum, proving to be an effective and valuable tool in TDM and immediate decision making in the doctor office or hospitals. Trial completion date: Apr 2023 --> Oct 2023 | Trial primary completion date: Apr 2023 --> Oct 2023
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
    Journal:  ABP 501 (adalimumab-atto) in the treatment of inflammatory bowel disease: an example of evidence-based extrapolation. (Pubmed Central) -  Nov 17, 2021   
    Trial completion date: Apr 2023 --> Oct 2023 | Trial primary completion date: Apr 2023 --> Oct 2023 We report the available evidence demonstrating the biosimilarity of ABP 501 (AMGEVITA®, adalimumab-atto) to its reference product (RP) (Humira®, adalimumab), and the rationale for the extrapolation of the results obtained with the RP in inflammatory bowel disease (IBD) to ABP 501.
  • ||||||||||  Yuflyma (adalimumab biosimilar) / Pfizer, Celltrion, Nippon Kayaku
    Journal:  Investigation of the Physicochemical and Biological Stability of the Adalimumab Biosimilar CT-P17. (Pubmed Central) -  Nov 10, 2021   
    Our data suggest that CT-P17 may be used without any significant loss of stability when stored at 5 °C or 25 °C with 60% relative humidity for up to 28 days, and was not impacted by protein concentration tested and delivery device. Comparative stability data suggest that the appropriate maximum storage period for CT-P17 may be up to 28 days at room temperature with 60% relative humidity.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
    Trial completion date, Trial primary completion date:  A Comparative Study Between ABP 501 and Humira (clinicaltrials.gov) -  Oct 29, 2021   
    P3,  N=414, Recruiting, 
    Further larger and longer studies are mandatory to understand the clinical implications of these findings. Trial completion date: Oct 2023 --> Apr 2023 | Trial primary completion date: Oct 2023 --> Apr 2023
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
    Enrollment open:  A Comparative Study Between ABP 501 and Humira (clinicaltrials.gov) -  Oct 14, 2021   
    P3,  N=414, Recruiting, 
    AB- 501 is an effective treatment for plaque-type psoriasis and psoriatic arthritis regardless if patients are originator-naïve or if they were switched from the reference product. Not yet recruiting --> Recruiting
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
    New P3 trial:  A Comparative Study Between ABP 501 and Humira (clinicaltrials.gov) -  Oct 10, 2021   
    P3,  N=414, Not yet recruiting,