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

  • Yoo, Dae Hyun
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초록

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.

키워드

affordabilitybiosimilarimmunogenicityinfliximabmicroheterogeneityrheumatoid arthritisswitchingINNOVATOR INFLIXIMABPARALLEL-GROUPDOUBLE-BLINDANTIBODIESEFFICACYSAFETYCT-P13METHOTREXATE
제목
The rise of biosimilars: potential benefits and drawbacks in rheumatoid arthritis
저자
Yoo, Dae Hyun
DOI
10.1586/1744666X.2014.932690
발행일
2014-08
유형
Editorial Material
저널명
Expert Review of Clinical Immunology
10
8
페이지
981 ~ 983