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Humira Biosimilars Clinical Trial Insight Report 2016: Patent Litigation Issues Involving Development of Humira (Adalimumab) Biosimilar - Research and Markets

Research and Markets
Posted on: 25 Oct 16

Research and Markets has announced the addition of the "Humira Biosimilars Clinical Trial Insight" clinical trials to their offering.

The Humira Biosimilars Clinical Trial Insight report gives comprehensive clinical insight on 33 biosimilars version of Humira drug in clinical pipeline. More than 10 of these biosimilars are in Phase-III trials and are expected to be commercially available in next 5-8 years. The patent protection assigned to Humira will expire in 2016 for US and 2018 for European market.

The Humira stands for Human Monoclonal Antibody in Rheumatoid Arthritis. It is also termed as Adalimumab or D2E7 and is a recombinant Immunoglobulin G1 monoclonal antibody which is specific for tumor necrosis factor alpha (TNF-a). It is a drug designed by the mode of recombinant DNA technology for the treatment of rheumatoid arthritis, psoriatic arthritis, Crohn's disease and ulcerative colitis. In the rheumatoid arthritis adalimumab has the equivalent efficacy as that of methotrexate.

The chemical and biological components of Humira define it as a TNF inhibiting anti-inflammatory biologic medication. It binds to the TNF-a which leads to the inflammatory response of autoimmune diseases but after the conjugation of Humira it reduces the inflammatory response.

The mechanism of action includes the binding of HUMIRA specifically to TNF-a and renders it incapable of binding to its receptors on cell surfaces. TNF-a exerts its pro-inflammatory role by binding to its cell surface receptor. When HUMIRA binds to the membrane bound version of TNF-a on TNF-a-producing cells, it can lead to lysis of these TNF-a producing cell in the presence of complement.

Humira (Adalimumab) Clinical Insight

  • Clinical Introduction
  • Company Partnerships & Agreements
  • Patent Analysis by Indication
  • Designated Orphan Status by Indication & Country
  • Brand Names by Country/Region

Humira Biosimilars Clinical Insight by Company

  • AET BioTech/BioXpress Therapeutics
  • Alphamab
  • Alteogen/Cristalia
  • Amgen
  • Axxo
  • Biocad
  • BIOCND/Genor Biopharma
  • Biocon/Mylan
  • Bionovis/The Instituto Vital Brazil
  • Boehringer Ingelheim
  • Celltrion
  • CinnaGen
  • Coherus BioSciences
  • Dong A ST/Meiji Seika Pharma
  • EMD Serono/Merck
  • Fujifilm Kyowa Kirin Biologics
  • Gene Techno Science
  • Harvest Moon Pharmaceuticals
  • Hetero Drugs
  • Innovent Biologics
  • LG Life Sciences
  • mAbxience
  • Meridian Biopharmaceuticals
  • Momenta Pharmaceuticals
  • Oncobiologics
  • Pfizer
  • PlantPraxis
  • Reliance Life Sciences
  • Samsung Bioepis
  • Sandoz
  • Shanghai Henlius Biotech
  • Therapeutic Proteins International
  • Zydus Cadila

For more information about this clinical trials report visit

View source version on

Business Wire

Last updated on: 25/10/2016

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