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Multicenter, Double-Blind, Randomized, 2-Arm, Parallel-Group, Equivalence Study Evaluating Efficacy and Safety Similarity of Mylan Adalimumab (MYL-1401A) Compared With Humira in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis

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Trial Profile

Multicenter, Double-Blind, Randomized, 2-Arm, Parallel-Group, Equivalence Study Evaluating Efficacy and Safety Similarity of Mylan Adalimumab (MYL-1401A) Compared With Humira in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2024

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Mylan

Most Recent Events

  • 25 Sep 2024 According to Biocon Media Release, new dermatology data from this study was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam. The presentation on 9:00am EDT, September 25, 2024, highlighted results from two separate pivotal Phase 3 clinical studies supported interchangeability between adalimumab and adalimumab-fkjp as well as underscoring biosimilarity of bUstekinumab.
  • 25 Sep 2024 According to Biocon Media Release, this study was conducted to fulfill the U.S. Food and Drug Administration (FDA) requirement for designation as an "interchangeable" and has been submitted to the FDA.
  • 25 Sep 2024 According to Biocon Media Release, new dermatology data from this study presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam.

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