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A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira in Subjects With Moderate to Severe Rheumatoid Arthritis

Trial Profile

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira in Subjects With Moderate to Severe Rheumatoid Arthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jul 2019

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Samsung Bioepis
  • Most Recent Events

    • 24 Jul 2019 According to an Samsung Bioepis media release, the US Food and Drug Administration (FDA) has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA(adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis based on the data derived from this trial.
    • 26 Sep 2018 According to a Samsung Bioepis media release, based on the data from this trial, the U.S. FDA has accepted for review the Biologics License Application (BLA) under the 351(k) pathway for SB5, a biosimilar candidate referencing HUMIRA (adalimumab). The BLA for SB5 was submitted by Samsung Bioepis in July 2018.
    • 24 Sep 2018 Results published in the BioDrugs.
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