Solymbic (adalimumab biosimilar) / Amgen 
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  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo, Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung, Mundipharma
    Clinical, Journal:  Switching from Biosimilar to Biosimilar Adalimumab, Including Multiple Switching, in Crohn's Disease: A Prospective Study. (Pubmed Central) -  Aug 8, 2021   
    We conducted a prospective, single-centre observational study in which we consecutively recruited all CD patients who switched from adalimumab biosimilar ABP 501 to biosimilar SB5 from January to July 2021...Seven patients (11.5%) experienced side effects, compared to one patient (1.6%) in the 6 pre-switch months (p = 0.03). In conclusion, switching from biosimilar to biosimilar of adalimumab did not lead to signs of safety or loss of efficacy other than those already known in the literature for the class of drugs.
  • ||||||||||  Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung, Mundipharma, Humira (adalimumab) / Eisai, AbbVie
    [VIRTUAL] LONG-TERM OUTCOMES FOLLOWING A SWITCH FROM ORIGINATOR ADALIMUMAB TO THE BIOSIMILAR SB5 (IMRALDI) IN IBD (Poster Exhibition) -  Jul 20, 2021 - Abstract #UEGW2021UEGW_4585;    
    The most common adverse event was injection site pain; these patients were successfully moved on to Amgevita providing the first data about a double biosimilar switch. Over the 24 months of this biosimilar ADA program substantial cost savings were effected.
  • ||||||||||  Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung, Mundipharma, Humira (adalimumab) / Eisai, AbbVie
    [VIRTUAL] LONG-TERM OUTCOMES FOLLOWING A SWITCH FROM ORIGINATOR ADALIMUMAB TO THE BIOSIMILAR SB5 (IMRALDI) IN IBD (Poster Exhibition) -  Jul 20, 2021 - Abstract #UEGW2021UEGW_2405;    
    The most common adverse event was injection site pain; these patients were successfully moved on to Amgevita providing the first data about a double biosimilar switch. Over the 24 months of this biosimilar ADA program substantial cost savings were effected.
  • ||||||||||  Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung, Mundipharma, Humira (adalimumab) / Eisai, AbbVie
    [VIRTUAL] LONG-TERM OUTCOMES FOLLOWING A SWITCH FROM ORIGINATOR ADALIMUMAB TO THE BIOSIMILAR SB5 (IMRALDI) IN IBD (Poster Exhibition) -  Jul 20, 2021 - Abstract #UEGW2021UEGW_574;    
    The most common adverse event was injection site pain; these patients were successfully moved on to Amgevita providing the first data about a double biosimilar switch. Over the 24 months of this biosimilar ADA program substantial cost savings were effected.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
    Clinical, Observational data, Journal:  Effectiveness and safety of adalimumab biosimilar ABP 501 in Crohn's disease: an observational study. (Pubmed Central) -  Jun 30, 2021   
    Over the 24 months of this biosimilar ADA program substantial cost savings were effected. our results support ABP 501 as an effective and well-tolerated drug, with a good interchangeability with its originator for the treatment of Crohn's disease.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
    Clinical, Journal:  Effectiveness and safety of switching to adalimumab biosimilar ABP 501 in Crohn's disease. (Pubmed Central) -  Jun 8, 2021   
    (Rev Esp Enferm Dig 2020; 112: 195-200)" demonstrate that the adalimumab biosimilar ABP 501 can determine the clinical benefit with a satisfactory safety profile until the end of follow-up in a group of patients with Crohn's disease. This result could have important practical implications as it supports the concept that a biosimilar -after the approval by the European Medicines Agency- is considered interchangeable with its originator.
  • ||||||||||  Humira (adalimumab) / Eisai, AbbVie, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] DIFFERENCES IN DRUG SURVIVAL BETWEEN ORIGINATOR AND BIOSIMILAR PRODUCTS AMONG FIRST USERS OF EACH MOLECULE (Posters Viewing) -  May 21, 2021 - Abstract #EULAR2021EULAR_2066;    
    Despite their identical indications and therapeutic positioning, there are some differences in the baseline characteristics between patients who start ADA, IFX and RIT and their biosimilars. There are no differences in drug survival between originator and biosimilar with the possible exception of etanercept although the observed difference should be interpreted in light of possible unmeasured or residual channeling.
  • ||||||||||  Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung, Mundipharma, Humira (adalimumab) / Eisai, AbbVie
    [VIRTUAL] Long-term outcomes following a switch from originator adalimumab to the biosimilar SB5 (Imraldi) in IBD (Virtual Poster Exhibition) -  May 5, 2021 - Abstract #ECCOIBD2021ECCO_IBD_563;    
    The most common adverse event was injection site pain; these patients were successfully moved on to Amgevita providing the first data about a double biosimilar switch. Over the 24 months of this biosimilar ADA program substantial cost savings were effected.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen
    Clinical, Journal:  Acupuncture and Related Techniques for Pain Relief and Treatment of Heroin Addiction: Mechanisms and Clinical Application. (Pubmed Central) -  Dec 29, 2020   
    It has been shown that the primary afferent sensory fibers, a mesolymbic neural circuit, and a descending inhibitory pathway are critical in acupuncture analgesia...Activation of CCKBR promotes formation of heteromerization of morphine-receptor and CCKBR. Interaction of the third transmembrane domain between the 2 receptors resulted in the reduced binding affinity of the opioid receptor.
  • ||||||||||  Review, Journal:  Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. (Pubmed Central) -  Dec 3, 2020   
    P1, P3
    Data from several switching studies showed no changes in efficacy, safety, trough serum drug concentration, or immunogenicity between the biosimilars and their RP.Trial registration: ClinicalTrials.gov identifiers: NCT02260791, NCT02405780, NCT01970475, NCT02137226, NCT02045979, NCT02744755, NCT02144714, NCT02167139, NCT03014947, NCT02114931, NCT02640612, NCT02640612, NCT02167139, NCT03052322, NCT02480153. EudraCT numbers: 2012-005140-23, 2012-000785-37, 2013-003722-84, 2015-000579-28, 2014-002879-29, 2014-000662-21, 2013-004654-13, 2015-002634-41, 2014-005229-11, 2016-002852-26, 2014-000352-29.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
    [VIRTUAL] SWITCHING FROM ADALIMUMAB ORIGINATOR TO ABP 501 BIOSIMILAR: A MULTICENTRIC NORTH ITALIAN STUDY (Poster Exhibition) -  Jul 19, 2020 - Abstract #UEGW2020UEGW_4606;    
    Our data shows that after switching, 1/3 of the patients may experience a disease relapse, requiring treatment optimization (i.e. addiction of steroids or increasing the dose to once a week) or treatment discontinuation. Thus, patients should be strictly observed in order to prevent or, at least, early manage such clinical relapses.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
    [VIRTUAL] SWITCHING FROM ADALIMUMAB ORIGINATOR TO ABP 501 BIOSIMILAR: A MULTICENTRIC NORTH ITALIAN STUDY (Poster Exhibition) -  Jul 19, 2020 - Abstract #UEGW2020UEGW_2630;    
    Our data shows that after switching, 1/3 of the patients may experience a disease relapse, requiring treatment optimization (i.e. addiction of steroids or increasing the dose to once a week) or treatment discontinuation. Thus, patients should be strictly observed in order to prevent or, at least, early manage such clinical relapses.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
    [VIRTUAL] SWITCHING FROM ADALIMUMAB ORIGINATOR TO ABP 501 BIOSIMILAR: A MULTICENTRIC NORTH ITALIAN STUDY (Poster Exhibition) -  Jul 19, 2020 - Abstract #UEGW2020UEGW_646;    
    Our data shows that after switching, 1/3 of the patients may experience a disease relapse, requiring treatment optimization (i.e. addiction of steroids or increasing the dose to once a week) or treatment discontinuation. Thus, patients should be strictly observed in order to prevent or, at least, early manage such clinical relapses.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
    Review, Journal:  A Review of the Totality of Evidence Supporting the Development of the First Adalimumab Biosimilar ABP 501. (Pubmed Central) -  May 19, 2020   
    The pivotal phase 3 study in patients with RA also established clinical similarity between ABP 501 and adalimumab RP; an open-label extension of this study demonstrated sustained efficacy over an additional 72 weeks, with no new safety or immunogenicity concerns with ABP 501 treatment. Overall, the TOE supported the conclusion that ABP 501 is highly similar to adalimumab RP and provided scientific justification for extrapolation to all the approved indications of adalimumab RP not protected by exclusivities.Funding: Amgen Inc.
  • ||||||||||  Journal:  Biosimilars of adalimumab: the upcoming challenge in IBD. (Pubmed Central) -  Apr 1, 2020   
    Expert opinion Biosimilars of adalimumab appear to be clinically equivalent to the RP. Decisions based on choosing the ideal patient to receive or to be switched to a biosimilar of adalimumab, or choosing one biosimilar vs. another, or cross-switching among biosimilars remain the next challenge in the field of IBD.
  • ||||||||||  Journal:  Biosimilars of adalimumab in IBD: are we ready for that? (Pubmed Central) -  Feb 16, 2020   
    Expert opinion: Biosimilars of adalimumab showed equivalent clinical efficacy to the RP in other immune-mediated diseases. However, defining the ideal patient's profile to receive or to be switched to a biosimilar, choosing one biosimilar vs. another, or cross-switching among biosimilars, will become the next challenge in IBD.
  • ||||||||||  Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    Clinical, Review, Journal:  Safety and Effectiveness of Anti-Tumor Necrosis Factor-Alpha Biosimilar Agents in the Treatment of Psoriasis. (Pubmed Central) -  Feb 13, 2020   
    In general, these biosimilar agents have been shown to have equivalent efficacy, tolerability, and immunogenicity profiles compared to their originators in patients with rheumatologic disease, although studies in patients with psoriasis are fairly limited. Additional switching studies and post-marketing safety analyses are needed to assess the interchangeability of biosimilar agents with their reference products.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
    Use of adalimumab biosimilar ABP 501 in Crohn’s disease: A real-life experience (Hall C - Poster exhibition) -  Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_1523;    
    No unexpected adverse events occurred during the study period. Conclusion Our results support ABP 501 as an efficacious and well-tolerated drug, at least in the short-term, and its interchangeability with its originator in the treatment of CD.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
    Switching from adalimumab originator to ABP 501 biosimilar: a multicentre North Italian study (Hall C - Poster exhibition) -  Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_1378;    
    Thus, patients should be strictly observed in order to prevent or, at least, early manage such clinical relapses. Larger and longer studies are mandatory to understand the clinical implications of these findings.
  • ||||||||||  Review, Journal:  Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis. (Pubmed Central) -  Oct 24, 2019   
    The introduction of adalimumab biosimilars will offer exciting opportunities in improving treatment access and increasing treatment options for RA and other licensed indications. Real-world data will further provide assurances on efficacy as well as safety.
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    Review, Journal:  Biosimilars in dermatology: The wind of change. (Pubmed Central) -  Aug 7, 2019   
    The debate over the future of biosimilars is far from being finished. The explosive development of biological therapy and the emergence of biosimilars represent a significant success in the effort to provide advanced healthcare to patients all over the world.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
    Journal:  Scientific and statistical considerations in evaluating the analytical similarity of ABP 501 to adalimumab. (Pubmed Central) -  Aug 7, 2019   
    Statistical considerations are used to establish objective assessment criteria. The result is a scientifically justified, objective analytical similarity assessment that demonstrates that a proposed biosimilar is structurally and functionally similar to a reference product.
  • ||||||||||  Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
    Trial completion:  Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA (clinicaltrials.gov) -  Apr 20, 2015   
    P3,  N=350, Completed, 
    Trial primary completion date: Sep 2016 --> Apr 2016 Active, not recruiting --> Completed