Adalimumab biosimilar - Biocon/Mylan

Drug Profile

Adalimumab biosimilar - Biocon/Mylan

Alternative Names: BMO 2; MYL 1401A

Latest Information Update: 23 Jul 2018

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At a glance

  • Originator Biocon
  • Developer Biocon; Mylan
  • Class Anti-inflammatories; Anti-TNF monoclonal antibodies; Antipsoriatics; Antirheumatics; Eye disorder therapies; Skin disorder therapies
  • Mechanism of Action Immunomodulators; Tumour necrosis factor alpha inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III Autoimmune disorders; Plaque psoriasis

Most Recent Events

  • 17 Jul 2018 AbbVie enters into HUMIRA® patent license agreements with Mylan for adalimumab biosimilar in USA and countries where AbbVie owns intellectual property, excluding Europe
  • 01 Mar 2017 Mylan completes a phase III trial in Plaque psoriasis in Bulgaria, Poland, Russia, Ukraine, Germany, Hungary and Estonia (SC) (NCT02714322)
  • 10 Jun 2015 Phase-III clinical trials in Plaque psoriasis in Germany, Hungary (SC) (EudraCT2014-003420-46) after June 2015
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