The rise of biosimilars: potential benefits and drawbacks in rheumatoid arthritis

Expert Rev Clin Immunol. 2014 Aug;10(8):981-3. doi: 10.1586/1744666X.2014.932690. Epub 2014 Jun 25.


Although biologic agents are effective in the treatment of rheumatoid arthritis, the high price of drugs and restricted health care budgets have restricted easy access to biologics. Eventually, the use of biologic disease-modifying antirheumatic drugs might be inversely associated with disease activity in countries with low gross domestic product. The EMA approved an infliximab biosimilar for the first time in September 2013. The first approval of a biosimilar monoclonal antibody by a major regulatory authority provided a global standard for subsequent biosimilars and for biopharmaceutical companies developing biosimilars. Biosimilars with a highly similar quality and efficacy profile at an acceptable lower cost would significantly increase affordability of biologic disease-modifying antirheumatic drugs in the treatment of rheumatoid arthritis. Here, we will review the current status of first biosimilar antibody agent and the potential discussion points raised against biosimilars. In addition, the importance of awareness on biosimilars for stakeholders is discussed.

Keywords: affordability; biosimilar; immunogenicity; infliximab; microheterogeneity; rheumatoid arthritis; switching.

Publication types

  • Editorial
  • Review

MeSH terms

  • Animals
  • Antibodies, Monoclonal / economics
  • Antibodies, Monoclonal / therapeutic use
  • Antirheumatic Agents / economics
  • Antirheumatic Agents / therapeutic use
  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / economics
  • Biosimilar Pharmaceuticals / economics
  • Biosimilar Pharmaceuticals / therapeutic use*
  • Drug Approval
  • Drug Substitution
  • Fees, Pharmaceutical
  • Health Services Accessibility
  • Humans
  • Infliximab


  • Antibodies, Monoclonal
  • Antirheumatic Agents
  • Biosimilar Pharmaceuticals
  • Infliximab