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  • ||||||||||  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.
  • ||||||||||  Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
    Clinical, Review, Journal, HEOR, Real-World Evidence:  Real-World Evidence on Etanercept Biosimilar SB4 in Etanercept-Naïve or Switching Patients: A Systematic Review. (Pubmed Central) -  Aug 7, 2019   
    Nearly 2500 ETN-naïve patients have been initiated on SB4 and outcomes are similar to those patients receiving reference ETN. Overall this systematic review of real-world evidence provides additional reassurance that SB4 is as effective and safe as reference ETN in both switched and naïve patients.
  • ||||||||||  Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
    Journal:  Implementing and delivering a successful biosimilar switch programme - the Berkshire West experience. (Pubmed Central) -  Aug 2, 2019   
    Drug acquisition costs were decreased by £95,000 with an overall reduction in prescribing costs of £186,000 for the local health economy. A managed switching programme from originator etanercept to biosimilar Benepali, using a novel fixed price model, delivers significant cost savings and investment in clinical services while maintaining similar patient-reported outcomes and good patient experience.
  • ||||||||||  Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
    Clinical, Journal:  Open-Label Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4: 6-Month Results From a Controlled Cohort Study. (Pubmed Central) -  Jul 24, 2019   
    A managed switching programme from originator etanercept to biosimilar Benepali, using a novel fixed price model, delivers significant cost savings and investment in clinical services while maintaining similar patient-reported outcomes and good patient experience. Non-mandatory transitioning from ENB to SB4 using a specifically-designed communication strategy showed a slightly lower persistence rate and smaller decreases in disease activity compared with a historical cohort, but these differences were considered as not being clinically relevant.
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    Journal:  How similar is biosimilar? A comparison of Infliximab therapeutics in regard to charge variant profile and antigen binding affinity. (Pubmed Central) -  Jul 19, 2019   
    We would therefore argue, that analytical comparison is not always a good predictor for clinical interchangeability. Any future regulatory framework for the approval of biosimilars should reflect that the parameters chosen for analytical comparability have to be chosen carefully.
  • ||||||||||  Erelzi (etanercept biosimilar) / Novartis, Enbrel (etanercept) / Takeda, Pfizer, Amgen
    Journal:  Etanercept for the treatment of rheumatoid arthritis. (Pubmed Central) -  Jun 26, 2019   
    With the increasing number of etanercept biosimilars, there will likely be a resurgence of their prescription. This article reviews the pharmacology, efficacy and safety of the etanercept reference product, and its biosimilars, in the context of RA treatment.
  • ||||||||||  Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
    Journal:  Etanercept biosimilar SB-4. (Pubmed Central) -  Jun 9, 2019   
    In some areas, and more specifically when it comes to immunogenicity, SB-4 showed lower incidents. Therefore, it is fully expected to have same efficacy and safety in all indications.
  • ||||||||||  Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
    Clinical, Journal:  Clinical experience with the etanercept biosimilar SB4 in psoriatic patients. (Pubmed Central) -  Jun 5, 2019   
    In cohort 2 at week 24 PASI 75 was observed in 75% of patients. Conclusion In our experience switching from originator to SB4 in psoriatic patients seems not to influence efficacy, especially cutaneous manifestations, over a median observational period of 24 weeks.
  • ||||||||||  Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
    Journal:  High-throughput screens for agonists of bone morphogenetic protein (BMP) signaling identify potent benzoxazole compounds. (Pubmed Central) -  May 7, 2019   
    Activation of BMP signaling by sb4 increased the phosphorylation of key second messengers (SMADs-1/5/9) and also increased expression of direct target genes (inhibitors of DNA binding, ID1 and ID3) in canonical BMP signaling. Our results underscore the feasibility of utilizing HTS to identify compounds that mimic key downstream events of BMP signaling in renal cells and yielded a lead BMP agonist.
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
    Review, Journal:  Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective. (Pubmed Central) -  Apr 27, 2019   
    However, efficacy and safety data on Flixabi (SB2) in IBD patients is lacking. Switching from the originator to a biosimilar in patients with IBD is acceptable, although scientific and clinical evidence is lacking regarding reverse switching, multiple switching and cross-switching among biosimilars in IBD patients.
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
    Journal:  Switching to biosimilars in the treatment of rheumatic diseases. (Pubmed Central) -  Apr 9, 2019   
    Expert Commentary: Clear guidelines for switching and data from post-marketing surveillance and registries will be required to confirm existing results on the safety and efficacy of switching from bio-originators to biosimilars. To lessen the nocebo effect against biosimilars, effective educational programs should be provided for all stakeholders, including patients and physicians.
  • ||||||||||  Eticovo (etanercept-ykro) / Biogen, Organon, Samsung, Ewopharma, Yuhan Corp, Mundipharma, Bionovis
    Trial completion:  Benepali (clinicaltrials.gov) -  Oct 23, 2018   
    P=N/A,  N=500, Completed, 
    The number of biosimilars and time of entry of is critical to create competition which will result in maximum cost savings. Recruiting --> Completed
  • ||||||||||  Stelara (ustekinumab) / J&J
    Enrollment change, Trial completion date, Trial primary completion date, Real-world evidence, Real-world effectiveness, Real-world:  RUN-CD: Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn (clinicaltrials.gov) -  Jul 13, 2018   
    P=N/A,  N=900, Recruiting, 
    Trial completion date: Oct 2018 --> Jan 2019 | Trial primary completion date: Aug 2018 --> Nov 2018 N=600 --> 900 | Trial completion date: May 2022 --> Mar 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
  • ||||||||||  Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
    Phase classification:  BENEFIT: Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel (clinicaltrials.gov) -  Apr 3, 2018   
    P,  N=600, Recruiting, 
    More RA patients used bDMARDs in recent years, and use of newer agents, including certolizumab, golumumab, and tocilizuamab, is rising, which highlights a need for further comparative safety and effectiveness research of these agents to better guide evidence-based decision making. Phase classification: P=N/A --> P
  • ||||||||||  Eticovo (etanercept-ykro) / Biogen, Organon, Samsung, Ewopharma, Yuhan Corp, Mundipharma, Bionovis
    Trial primary completion date:  Benepali (clinicaltrials.gov) -  Dec 21, 2017   
    P=N/A,  N=500, Recruiting, 
    Not yet recruiting --> Recruiting Trial primary completion date: Dec 2017 --> Aug 2018
  • ||||||||||  Eticovo (etanercept-ykro) / Biogen, Organon, Samsung, Ewopharma, Yuhan Corp, Mundipharma, Bionovis
    New trial:  Benepali (clinicaltrials.gov) -  Oct 31, 2017   
    P=N/A,  N=500, Recruiting,