Rituximab biosimilar - Celltrion

Drug Profile

Rituximab biosimilar - Celltrion

Alternative Names: CT-P10; Truxima

Latest Information Update: 30 Dec 2016

Price : $50

At a glance

  • Originator Celltrion
  • Class Antineoplastics; Antirheumatics; Monoclonal antibodies
  • Mechanism of Action B cell inhibitors; CD20 antigen inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Registered Chronic lymphocytic leukaemia; Non-Hodgkin's lymphoma; Rheumatoid arthritis
  • Preregistration Follicular lymphoma; Microscopic polyangiitis; Wegener's granulomatosis

Most Recent Events

  • 15 Dec 2016 Committee for Medicinal Products for Human Use (CHMP) of EMA recommends approval of rituximab biosimilar for Diffuse large B cell lymphoma, Follicular lymphoma, Chronic lymphocytic leukaemia (CLL), Wegener's granulomatosis, Microscopic polyangitis and Rheumatoid arthritis in European Union
  • 17 Nov 2016 Registered for Chronic lymphocytic leukaemia in South Korea (IV)
  • 17 Nov 2016 Registered for Non-Hodgkin's lymphoma in South Korea (IV)
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