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A Multicenter, Randomized, Parallel Group Treatment, Double-Blind, 2-arm Study to Investigate the Comparative Efficacy, Safety, and Immunogenicity Between Subcutaneous AVT05 and EU-approved Simponi in Combination with Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis

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A Multicenter, Randomized, Parallel Group Treatment, Double-Blind, 2-arm Study to Investigate the Comparative Efficacy, Safety, and Immunogenicity Between Subcutaneous AVT05 and EU-approved Simponi in Combination with Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2025

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At a glance

  • Drugs Golimumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms ALVOFLEX
  • Sponsors Alvotech

    • Most Recent Events

    • 27 Jan 2025 According to an Alvotech Media Release, the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, to treat a variety of inflammatory conditions. These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. The FDA review process for these applications is anticipated to be completed in the fourth quarter of 2025.
    • 04 Nov 2024 According to an Alvotech Media Release, the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05 to treat several chronic inflammatory diseases.The approvals process is anticipated to be completed in the fourth quarter of 2025.
    • 02 Oct 2024 Status changed from active, no longer recruiting to completed.

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