Cetuximab biobetter - Glycotope

Drug Profile

Cetuximab biobetter - Glycotope

Alternative Names: CetuGEX™; Cetuximab biosimilar - Glycotope; GT-MAB 5.2-GEX

Latest Information Update: 20 May 2016

Price : $50

At a glance

  • Originator GLYCOTOPE
  • Developer Glycotope
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action Epidermal growth factor receptor antagonists
  • Orphan Drug Status

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

  • 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Head and neck cancer
  • Phase I/II Colorectal cancer; Gastric cancer; Non-small cell lung cancer; Renal cancer
  • Phase I Solid tumours

Most Recent Events

  • 20 May 2016 Cetuximab biobetter is still in phase II trials for Head and neck cancer (Late-stage disease, Metastatic disease, Recurrent) in Belgium, Germany, France, Italy, Poland, Romania and Spain
  • 20 May 2016 Phase-I/II development for Colorectal cancer, Non-small cell lung cancer, Gastric cancer and Renal cancer is ongoing in Germany
  • 15 Mar 2016 Biomarkers information updated
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