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A pharmacokinetic and bioequivalence study of adalimumab biosimilar (CHS-1420)

Trial Profile

A pharmacokinetic and bioequivalence study of adalimumab biosimilar (CHS-1420)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Dec 2021

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Psoriasis; Rheumatoid arthritis
  • Focus Pharmacokinetics; Registrational
  • Most Recent Events

    • 20 Dec 2021 According to a Coherus Biosciences media release, the United States Food and Drug Administration (FDA) approved YUSIMRY (adalimumab-aqvh), formerly CHS-1420, a Humira (adalimumab) biosimilar product. Approval was based on a comprehensive data package that demonstrated the biosimilarity of YUSIMRY to the reference product, Humira. Data included results from Study CHS-1420-02 and CHS-1420-03
    • 28 Aug 2017 Results published in a Coherus Biosciences Media Release.
    • 02 Mar 2017 Results published in a Coherus Biosciences media release.
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