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Journal Abstract Search

657 related items for PubMed ID: 26365396

  • 1. Biosimilar monoclonal antibodies: the scientific basis for extrapolation.
    Schellekens H, Lietzan E, Faccin F, Venema J.
    Expert Opin Biol Ther; 2015; 15(11):1633-46. PubMed ID: 26365396
    [Abstract] [Full Text] [Related]

  • 2. The immunogenicity of biosimilar infliximab: can we extrapolate the data across indications?
    Ben-Horin S, Heap GA, Ahmad T, Kim H, Kwon T, Chowers Y.
    Expert Rev Gastroenterol Hepatol; 2015; 9 Suppl 1():27-34. PubMed ID: 26395532
    [Abstract] [Full Text] [Related]

  • 3. The Budget Impact of Biosimilar Infliximab (Remsima®) for the Treatment of Autoimmune Diseases in Five European Countries.
    Jha A, Upton A, Dunlop WC, Akehurst R.
    Adv Ther; 2015 Aug; 32(8):742-56. PubMed ID: 26343027
    [Abstract] [Full Text] [Related]

  • 4. The scientific and regulatory rationale for indication extrapolation: a case study based on the infliximab biosimilar CT-P13.
    Reinisch W, Louis E, Danese S.
    Expert Rev Gastroenterol Hepatol; 2015 Aug; 9 Suppl 1():17-26. PubMed ID: 26395531
    [Abstract] [Full Text] [Related]

  • 5. Infliximab Biosimilar (CT-P13; Infliximab-dyyb): A Review in Autoimmune Inflammatory Diseases.
    Blair HA, Deeks ED.
    BioDrugs; 2016 Oct; 30(5):469-480. PubMed ID: 27650650
    [Abstract] [Full Text] [Related]

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  • 7. Application of the FDA Biosimilar Extrapolation Framework to Make Off-Label Determinations.
    Li E, Lobaina E.
    J Manag Care Spec Pharm; 2017 Dec; 23(12):1227-1232. PubMed ID: 29172978
    [Abstract] [Full Text] [Related]

  • 8. Scientific rationale behind the development and approval of biosimilar infliximab (CT-P13) in Europe.
    Müller-Ladner U, Hong S, Oh C, Taylor P.
    Expert Rev Clin Immunol; 2015 Dec; 11 Suppl 1():S5-14. PubMed ID: 26395832
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  • 10. Harmonization of Infliximab and Anti-Infliximab Assays Facilitates the Comparison Between Originators and Biosimilars in Clinical Samples.
    Gils A, Van Stappen T, Dreesen E, Storme R, Vermeire S, Declerck PJ.
    Inflamm Bowel Dis; 2016 Apr; 22(4):969-75. PubMed ID: 26954707
    [Abstract] [Full Text] [Related]

  • 11. Experience with Biosimilar Infliximab (Remsima®) in Norway.
    Jahnsen J, Kaasen Jørgensen K.
    Dig Dis; 2017 Apr; 35(1-2):83-90. PubMed ID: 28147374
    [Abstract] [Full Text] [Related]

  • 12. IBD: Indication extrapolation for anti-TNF biosimilars.
    Vande Casteele N, Sandborn WJ.
    Nat Rev Gastroenterol Hepatol; 2015 Jul; 12(7):373-4. PubMed ID: 26077557
    [Abstract] [Full Text] [Related]

  • 13. Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody.
    Isaacs JD, Cutolo M, Keystone EC, Park W, Braun J.
    J Intern Med; 2016 Jan; 279(1):41-59. PubMed ID: 26403380
    [Abstract] [Full Text] [Related]

  • 14. Biosimilar Monoclonal Antibodies for Inflammatory Bowel Disease: Current Comfort and Future Prospects.
    Gecse KB, Lakatos PL.
    Drugs; 2016 Oct; 76(15):1413-1420. PubMed ID: 27638739
    [Abstract] [Full Text] [Related]

  • 15. A Critical Review of Biosimilars in IBD: The Confluence of Biologic Drug Development, Regulatory Requirements, Clinical Outcomes, and Big Business.
    Ha CY, Kornbluth A.
    Inflamm Bowel Dis; 2016 Oct; 22(10):2513-26. PubMed ID: 27564646
    [Abstract] [Full Text] [Related]

  • 16. Infliximab Biosimilars in the Treatment of Inflammatory Bowel Diseases: A Systematic Review.
    Radin M, Sciascia S, Roccatello D, Cuadrado MJ.
    BioDrugs; 2017 Feb; 31(1):37-49. PubMed ID: 28035633
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  • 18. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars?
    Lee H.
    AAPS J; 2014 Jan; 16(1):22-6. PubMed ID: 24114449
    [Abstract] [Full Text] [Related]

  • 19. Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study.
    Benucci M, Gobbi FL, Bandinelli F, Damiani A, Infantino M, Grossi V, Manfredi M, Parisi S, Fusaro E, Batticciotto A, Sarzi-Puttini P, Atzeni F, Meacci F.
    Immunol Res; 2017 Feb; 65(1):419-422. PubMed ID: 27449503
    [Abstract] [Full Text] [Related]

  • 20. Analysis of clinical trials of biosimilar infliximab (CT-P13) and comparison against historical clinical studies with the infliximab reference medicinal product.
    Yoo DH, Oh C, Hong S, Park W.
    Expert Rev Clin Immunol; 2015 Feb; 11 Suppl 1():S15-24. PubMed ID: 26395833
    [Abstract] [Full Text] [Related]

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