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.
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:
The group also arrived at 8 consensus recommendations:
The group concluded that the rapidly growing body of evidence has begun to reduce uncertainty about the use of biosimilars in treating rheumatic diseases. However, a treating physician should be the only one to decide whether to prescribe a biosimilar in place of a reference product, on a case-by-case basis, with the full awareness of the patient. While there is sufficient evidence about the safety and efficacy of biosimilars to allow for extrapolation of indications, there are not yet enough data to allay all concerns about switching among biosimilars or switching repeatedly between the reference and a biosimilar. To facilitate informed decision-making, providers are encouraged to gather pharmacovigilance data about the outcome of such switches.