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A Randomised, Single-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

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Trial Profile

A Randomised, Single-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 Jan 2023

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ankylosing spondylitis; Crohn's disease; Hidradenitis suppurativa; Juvenile rheumatoid arthritis; Plaque psoriasis; Psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Spondylarthritis; Ulcerative colitis; Uveitis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Samsung Bioepis

    • Most Recent Events

    • 03 Jan 2023 Results presented in a Samsung Bioepis Media Release.
    • 03 Jan 2023 According to a Samsung Bioepis media release, based on the data from this study, Health Canada has approved HADLIMA (also known as SB5) - a citrate-free, high concentration (40 mg/0.4 ML) formulation of biosimilar referencing HUMIRA(adalimumab).
    • 17 Aug 2022 According to a Samsung Bioepis media release, based on results of this study the U.S. Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA (adalimumab).

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