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  • ||||||||||  [VIRTUAL] CHARACTERIZATION OF PATIENTS WITH ANKYLOSING SPONDYLITIS WHO INITIATED SECUKINUMAB: ELECTRONIC HEALTH RECORDS DATA FROM THE COLUMBUS REPOSITORY (Poster View) -  May 22, 2020 - Abstract #EULAR2020EULAR_2048;    
    Physician and patient characteristics, and treatment patterns were reported for patients who were prescribed secukinumab and TNFis (adalimumab, etanercept, certolizumab pegol, infliximab, infliximab-abda, and golimumab)...Secukinumab initiators were more likely to have prior opioid use vs TNFi initiators but were less likely to have prior methotrexate use ( Figure 2 A ); 67% of secukinumab initiators and 49% of TNFi initiators were biologic experienced, of whom 73% and 76%, respectively, used 1 prior biologic, 25% and 20% used 2 prior biologics, and 2% and 4% used ≥ 3 prior biologics ( Figure 2 B )... Secukinumab initiators with AS were younger and more opioid and biologic experienced, were more likely to have a PsA diagnosis, and were more likely to discontinue their previous biologic because the biologic was no longer required compared to patients who initiated TNFis.
  • ||||||||||  Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
    Enrollment change, Trial completion date, Trial primary completion date:  PERFUSE: One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study (clinicaltrials.gov) -  Mar 30, 2020   
    P=N/A,  N=3000, Recruiting, 
    No abstract available N=1500 --> 3000 | Trial completion date: Jul 2021 --> Jun 2022 | Trial primary completion date: Jul 2021 --> Jun 2022
  • ||||||||||  Remicade (infliximab) / J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
    New P2 trial, Checkpoint inhibition:  Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis (clinicaltrials.gov) -  Mar 12, 2020   
    P2,  N=42, Not yet recruiting, 
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Entyvio (vedolizumab) / Takeda, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    [VIRTUAL] LONGITUDINAL EVALUATION OF PRODUCT UTILIZATION AND CHARACTERISTICS AMONG PATIENTS TREATED WITH BIOLOGIC ANTI-INFLAMMATORY AGENTS- A STUDY BY THE BIOLOGICS AND BIOSIMILARS COLLECTIVE INTELLIGENCE CONSORTIUM. () -  Mar 8, 2020 - Abstract #ISPOR2020ISPOR_91;    
    A total of 651 incident users of the biosimilar infliximab-dyyb (4.2% of all infliximab use), and 39 new users (0.2%) of infliximab-abda were observed...The proportion of rituximab users declined from 64.7% of all non-TNF use in 2012 to 37.9% in 2017, while use of newer products including vedolizumab and secukinumab have gradually increased to 9.6% and 12.9%, respectively, by 2017...With multiple biosimilars and new innovator products becoming available we expect the market shares will continue to shift. This is important information to inform future research in AIs in the BBCIC DRN.
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    [VIRTUAL] LOWER DRUG PRICES IN MEDICARE- IMPACT OF BIOSIMILAR INTRODUCTION () -  Mar 8, 2020 - Abstract #ISPOR2020ISPOR_69;    
    Conclusions Entry of biosimilar competition correlated with declining Medicare Part B payments for both innovator products and their biosimilars. As a result, the federal government and patients have benefited not only from lower-cost biosimilars, but also from declining prices of reference products.
  • ||||||||||  Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    [VIRTUAL] DO US COMMERCIAL HEALTH PLANS PRIORITIZE BIOSIMILAR COVERAGE? AN EMPIRICAL STUDY () -  Mar 8, 2020 - Abstract #ISPOR2020ISPOR_59;    
    We found that the included US commercial health plans varied with regard to how they prioritized coverage of biosimilars products. Our study suggests that the lack of preferred biosimilar coverage may contribute to the lower uptake of biosimilars in the US.
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
    The Budget Impact of a Biosimilar Transition Policy for Rheumatoid Arthritis Patients in Alberta () -  Feb 19, 2020 - Abstract #CRAAHPA2020CRA-AHPA_249;    
    A transition policy to biosimilars could reduce healthcare system costs although the savings may not be as high as expected depending on the implementation policy and retention rates. Further analyses should include costs beyond the drug costs as well as patient outcomes.
  • ||||||||||  Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen, Mundipharma
    Journal:  Etanercept biosimilar SB4 in the treatment of chronic plaque psoriasis. Data from the Psobiosimilars registry. (Pubmed Central) -  Feb 16, 2020   
    Real life data of etanercept biosimilar SB4 in patients with chronic plaque psoriasis (n=44) are only available only from the study of Egeberg A et al. who found that there were no significant differences in discontinuation risk between etanercept originator and biosimilar SB4.
  • ||||||||||  Review, Journal:  Drugs for psoriatic arthritis. (Pubmed Central) -  Feb 15, 2020   
    who found that there were no significant differences in discontinuation risk between etanercept originator and biosimilar SB4. No abstract available
  • ||||||||||  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.
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    SWITCHING INFLIXIMAB BIOSIMILAR: NO ADVERSE IMPACT ON IBD CONTROL OR DRUG LEVELS WITH FIRST OR SECOND SWITCH () -  Jan 28, 2020 - Abstract #DDW2020DDW_2212;    
    In a cohort of IBD patients switching to a new IFX biosimilar either for the first or second time, an increase in IFX level was observed with no impact on clinical and biochemical disease activity indices. Switching IFX biosimilars in IBD appears safe in the short term with respect to maintaining drug pharmacokinetic profile and disease control whether switching for the first or second time.
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    Clinical, Journal, Real-World Evidence:  The Role of Biosimilars in Uveitis: Long-Term Real-World Outcomes of the Switch From Original to Biosimilar TNF-Alpha Inhibitors. (Pubmed Central) -  Jan 12, 2020   
    No statistically significant changes were observed in the BCVA (p = 0.27), CMT (p = 0.50), frequency of UME (p = 0.57) and daily corticosteroid intake (p = 0.42) between the time of the switch and the last follow-up visit. The switch to biosimilars represents a feasible treatment choice associated with the maintenance of clinical efficacy in patients with non-infectious uveitis previously treated with the corresponding originator anti-TNF-α biologic agents.
  • ||||||||||  Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    PERFUSE: A french non-interventional cohort study of infliximab-naive and transitioned patients receiving infliximab biosimilar SB2; An interim analysis (Hall C - Poster exhibition) -  Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_1547;    
    Reasons for discontinuation (n) were: adverse event (9), primary loss of response (7), secondary loss of response (12) and unspecified (16).Conclusion This IA indicates that patients with IBD can be successfully and safely transitioned from reference or biosimilar IFX to SB2, with no loss of disease control and without need for dose escalation. Over 90% of transitioned patients continued SB2 treatment at M12 post-initiation.
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    Switching infliximab biosimilar: No adverse impact on inflammatory bowel disease control or drug levels with the first or second switch (Hall C - Poster exhibition) -  Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_1395;    
    Conclusion In a cohort of IBD patients switching to a new IFX biosimilar either for the first or second time, an increase in IFX level was observed with no impact on clinical and biochemical disease activity indices. Switching IFX biosimilars in IBD appears safe in the short term with respect to maintaining drug pharmacokinetic profile and disease control whether switching for the first or second time.
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    Safety and clinical efficacy of double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicentre study (Hall C - Poster exhibition) -  Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_1270;    
    No differences in IFX discontinuation, AE and clinical remission rates were found between double-switched and single-switched patients. No clinical parameters were found to predict safety and efficacy outcomes.Conclusion The study supports both safety and efficacy of the double switch from IFX originator to CT-P13 and SB2 in patients with IBD, and demonstrates its non-inferiority to a single switch strategy, with potential cost implications.
  • ||||||||||  Preclinical, Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFα BIologicals in Rheumatoid Arthritis (clinicaltrials.gov) -  Dec 24, 2019   
    P=N/A,  N=250, Terminated, 
    No clinical parameters were found to predict safety and efficacy outcomes.Conclusion The study supports both safety and efficacy of the double switch from IFX originator to CT-P13 and SB2 in patients with IBD, and demonstrates its non-inferiority to a single switch strategy, with potential cost implications. N=720 --> 250 | Trial completion date: Dec 2018 --> Dec 2019 | Recruiting --> Terminated | Trial primary completion date: May 2018 --> Dec 2019
  • ||||||||||  budesonide / Generic mfg., Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    Drug-Induced Liver Injury (DILI) Associated With Anti-tumor Necrosis Factor Alpha (Anti-TNFα) Agent () -  Dec 11, 2019 - Abstract #AIBD2019AIBD_65;    
    Acute liver injury caused by anti-TNFα antagonist may be a class effect since several agents in this category have been implicated. In this case, the most common presentation occurred as an autoimmune phenotype with marked hepatocellular injury.
  • ||||||||||  Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
    Journal:  Antiproliferative, neurotoxic, genotoxic and mutagenic effects of toxic cyanobacterial extracts. (Pubmed Central) -  Nov 27, 2019   
    SB4, Oscillatoria earlei SB5, Phormidium sp...On the other hand, all concentrations of five toxic cyanobacterial extracts induced DNA damage between 3.0% and 1.3% of tail intensity and did not cause any direct mutagenic effect at the 1000 µg/plate cyanobacterial extracts. These results suggest that cyanobacteria-derived MCLR is a promising candidate for development of effective agents against colon cancer.
  • ||||||||||  Journal:  Drugs for psoriasis. (Pubmed Central) -  Nov 13, 2019   
    In general, immunogenicity parameters of biosimilars are similar to those of their reference products. No abstract available
  • ||||||||||  Erelzi (etanercept biosimilar) / Novartis
    Review, Journal:  Review of Biosimilar Trials and Data on Etanercept in Rheumatoid Arthritis. (Pubmed Central) -  Oct 24, 2019   
    Trial data demonstrates subtle differences in clinical outcomes and adverse events between the biosimilars and the reference product (RP). The development of etanercept biosimilars may reduce the financial burden of treating RA, but real-world data regarding efficacy and safety in comparison to the RP will be vital to assess for meaningful differences.