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Inventi Impact: Biosimilars & Biopharmaceuticals

Articles

  • Inventi:pbs/31866/20
    Comparative Clinical Efficacy and Safety of the Proposed Biosimilar ABP 710 with Infliximab Reference Product in Patients with Rheumatoid Arthritis
    Research 2020 : July - September
    Mark C Genovese, Juan Sanchez-Burson, MyungShin Oh, Eva Balazs, Jeffrey Neal, Andrea Everding, Tomas Hala, Rafal Wojciechowski, Gary Fanjiang, Stanley Cohen

    Background: ABP 710 is being developed as a biosimilar to infliximab reference product (RP). Analytical similarity\nand pharmacokinetic equivalence between the two have been previously demonstrated. Here we report results\nfrom a comparative clinical study that evaluated the efficacy and safety of ABP 710 relative to the RP in patients\nwith rheumatoid arthritis (RA).\nMethods: In this multicenter, randomized, double-blind, 50-week equivalence study, patients with moderate to\nsevere active RA despite methotrexate received 3-mg/kg infusions of ABP 710 or RP at predetermined intervals\nbased on initial randomization and then with re-randomization at week 22. The primary endpoint was response\ndifference (RD) of ACR20 at week 22, with clinical equivalence evaluated based on.............

    How to Cite this Article
    Attribution/ CC Compliant Citation: Genovese, Mark C., et al.\n\"Comparative clinical efficacy and safety of the proposed\nbiosimilar ABP 710 with infliximab reference product in patients\nwith rheumatoid arthritis.\" Arthritis Research & Therapy 22.1\n(2020): 1-11.\nhttps://doi. 10.1186/s13075-020-2142-1\nhttp://creativecommons.org/licenses/by/4.0/\nSome formatting elements, header, footer, logos, dates and\npagination were modified while adapting this article.
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