Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo 
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 11 Diseases   10 Trials   10 Trials   362 News 


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  • ||||||||||  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
  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Clinical, Journal:  Comparison of treatment retention of originator vs biosimilar products in clinical rheumatology practice in Sweden. (Pubmed Central) -  Sep 10, 2022   
    We propose an MRI screening protocol to identify those at high risk of demyelination; positive results can be maximised by screening all patients with IIU and those with neurological symptoms. This large observational study supports the equivalence of biologic DMARD biosimilar products and originators when used in routine rheumatology care.
  • ||||||||||  Humira (adalimumab) / Eisai, AbbVie
    Increasing to weekly adalimumab dosing leads to improved psoriasis outcomes- a retrospective single centre review of real-world data () -  Aug 16, 2022 - Abstract #ESDR2022ESDR_351;    
    Adalimumab (Amgevita) was the first biologic agent in 84% (38/45)...16/45 had switched to an alternative biologic and 3/45 had methotrexate added at the point of data collection...4/12 had undetectable levels on both occasions, all of which had antibodies. In conclusion, real-world data demonstrates that adalimumab dose escalation is an effective treatment strategy when standard dosing is ineffective, with co-existing potential economic benefit versus switching.
  • ||||||||||  Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo, Humira (adalimumab) / Eisai, AbbVie
    Safety And Efficacy Of Amgevita™, Adalimumab Biosimilar, A Real-Life Study. (Screen # 1) -  Aug 7, 2022 - Abstract #PANLAR2022PANLAR_211;    
    Table Features Switched patients (n=54) De novo patients (n=29) Total (n=83) Male sex, n (%) 11 (38) 33 (61) 44 (54) Mean age (sd) 46.5 (16.8) 50.2 (19.5) 47.8 (17.7) Rheumatoid arthritis, n (%) 7 (13) 16 (55) 23 (28) Psoriatic arthritis (%) 17 (31.5) 2 (7) 19 (23) Spondyloarthritis, n (%) 7 (13) 1 (3.5) 8 (10) 17 (31.5) 6 (11) 23 (28) Others 7 (13) 4 (14) 11 (13) >=1 comorbidity 26 (48) 14 (48) 40 (48) Inflammatory (%) bowel disease, n Conclusion This real-life study showed good effectiveness and survival in patients treated with an Adalimumab biosimilar. No statistically significant difference in serious adverse events was observed between the two drugs.
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo, Erelzi (etanercept biosimilar) / Novartis
    Clinical, Journal:  Penetration rate of anti-TNF biosimilars and savings at 5 years after their introduction in French hospitals. (Pubmed Central) -  Aug 4, 2022   
    This study shows firstly that the penetration rate of anti-TNF biosimilars in France 5 years after their launch is close to 80%. Secondly, we show that the cost savings generated by the use of biosimilars to anti-TNF agents exceed 820 million Euro over 5 years.
  • ||||||||||  Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
    Clinical data, Journal:  The effect of biosimilar administration on clinical outcomes in patients with adalimumab-controlled psoriasis. (Pubmed Central) -  Jun 8, 2022   
    Previously limited to Humira, new biosimilar medications have now emerged including Amgevita...This audit of a single dermatology centre suggests switching to a biosimilar adalimumab may exacerbate symptoms of psoriasis. Future studies should investigate whether findings are restricted to our study population, and consider the influence of other factors, such as disease subtypes and medication formulations.
  • ||||||||||  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
  • ||||||||||  Trial completion date, Trial primary completion date:  FREE: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease (clinicaltrials.gov) -  May 18, 2022   
    P4,  N=148, Recruiting, 
    No difference in efficacy and safety was found between ADA biosimilars. Trial completion date: Apr 2022 --> Jun 2023 | Trial primary completion date: Apr 2022 --> Jun 2023
  • ||||||||||  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