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A randomised, double-blind, multicentre study comparing the efficacy, safety and immunogenicity of proposed Abatacept biosimilar (DRL_AB) with Orencia® administered by the intravenous route as an add-on to methotrexate in the treatment of patients with moderate to severe rheumatoid arthritis - AB-01-004

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Trial Profile

A randomised, double-blind, multicentre study comparing the efficacy, safety and immunogenicity of proposed Abatacept biosimilar (DRL_AB) with Orencia® administered by the intravenous route as an add-on to methotrexate in the treatment of patients with moderate to severe rheumatoid arthritis - AB-01-004

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Mar 2026

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At a glance

  • Drugs Abatacept (Primary) ; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Dr Reddys Laboratories

Most Recent Events

  • 20 Feb 2026 According to a Dr Reddys Laboratories media release, USFDA has accepted Dr. Reddy's 351(k) Biologics License Application (BLA) for Proposed Interchangeable biosimilar Abatacept, DRL_AB (IV for Infusion) that was submitted in December 2025.
  • 10 Sep 2025 New trial record

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