Global Experts Provide Consensus-Based Recommendations for Rheumatology Biosimilars

In an effort to provide a guide for clinicians and a framework for future educational efforts, an international panel of healthcare stakeholders convened to arrive at consensus recommendations for the use of biosimilars to treat rheumatological diseases.
Kelly Davio
September 18, 2017
In an effort to provide a guide for clinicians and a framework for future educational efforts, an international panel of healthcare stakeholders convened to arrive at consensus recommendations for the use of biosimilars to treat rheumatological diseases. The resulting recommendations were published in Annals of the Rheumatic Diseases.

The multidisciplinary task force—25 experts from Europe, Japan, and the United States (17 rheumatologists, 1 rheumatologist/regulator, 1 dermatologist, 1 gastroenterologist, 2 pharmacologists, 2 patients with rheumatic diseases, and 1 research fellow—convened in 2016 to develop an evidence-based, consensus-based statement on biosimilars after appraising evidence in the scientific literature. The task force members deliberated and revised statements on overarching principles and recommendations, which were later voted on and accepted if an 80% consensus was met. 

The group agreed on 5 overarching principles:
  • Treatment of rheumatic diseases is based on a shared decision-making process between patients and rheumatologists. Rheumatologists must educate patients about the disease process and appropriate treatments. Once informed, the patient can discuss preferences, goals, and the risks and benefits of specific treatments.
  • Contextual aspects of the healthcare system should be considered when making treatment decisions. The structure of health systems varies by country, and in nations like the United States, where patients must pay a portion of the cost of their treatments, necessary treatment can be inaccessible to some patients. These factors must be considered when selecting an appropriate therapy option.
  • A biosimilar approved in a highly regulated area is not better or worse than the originator product. A biosimilar that has satisfied requirements of a regulatory approval pathway can be expected to be the same as its reference in terms of efficacy, and will not have inferior safety to various batches of the reference. Efficacy and safety of a biosimilar can be expected to remain highly comparable with its reference product over time.
  • Patients and providers should be informed about the nature of the approval process, safety, and efficacy of biosimilars. The misconception that biosimilars may be of lesser quality because of their lower price point can be addressed through education about biosimilarity.
  • Harmonized methods should be established to obtain reliable pharmacovigilance data (including traceability) on both biosimilars and reference products. Regardless of the methods used to distinguish among biosimilars and reference products, batch numbers are essential to tracing problems, and should be carefully recorded.


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