Guidelines for Biosimilar Use for Treatment of Rheumatologic Diseases
Use of these agents by clinicians will help increase the number of available treatment options and control the rapidly expanding cost of bio-originators.
Consensus recommendations on the use of biosimilars for the treatment of patients with rheumatologic diseases were recently published in Annals of the Rheumatic Diseases. Use of these agents by clinicians will help increase the number of available treatment options and control the rapidly expanding cost of bio-originators.
The objective of this analysis was to develop a consensus-based statement on the use of biosimilars to treat inflammatory disorders by identifying and critically evaluating the evidence in the literature. An international multidisciplinary task force on biosimilars convened in 2016. A total of 25 experts and patients from the United States, Japan, and 8 European countries were involved, including 17 rheumatologists, 1 rheumatologist/regulator, 1 dermatologist, 1 gastroenterologist, 2 pharmacologists, 2 patients with rheumatic diseases, and 1 research fellow.
Four key topics were identified for further discussion by the task force: issues regarding clinical trials of biosimilars, extrapolation of indications, immunogenicity of biosimilars compared with their bio-originators, and switching between bio-originators and biosimilars, as well as switching among biosimilars. Specific questions related to these subjects were formulated to guide a systemic literature review, which identified relevant publications through November 2016. A total of 29 full-text articles were included in the review, along with 20 abstracts from the American College of Rheumatology and European League Against Rheumatism 2015 and 2016 conference databases.
The task force identified 5 overarching principles and 8 consensus recommendations for the treatment of rheumatologic diseases with biosimilars:
5 Overarching Principles
- Treating rheumatic diseases is a shared decision-making process between patients and their rheumatologists.
- When treatment decisions are made, the contextual aspects of the healthcare system should be taken into account.
- A biosimilar, as a substance that is approved by authorities in a highly regulated area, is neither more or less effective, nor inferior in safety, to its bio-originator.
- Patients and healthcare providers should be informed about the nature of biosimilars, their approval process, and their safety and efficacy.
- Harmonized methods should be established to gain reliable pharmacovigilance data, including traceability, about both biosimilars and bio-originators.
8 Consensus Recommendations
- Availability of biosimilars must significantly lower the cost of treating an individual patient, and must increase access to optimal therapy for all patients with rheumatic diseases.
- Approved biosimilars can be used to treat appropriate patients in the same way as their bio-originators.
- Antidrug antibodies to biosimilars need not be measured in clinical practice, given that no clinically significant differences in immunogenicity between biosimilars and their bio-originators have been detected.
- Relevant preclinical and phase I data about a biosimilar should be available when phase III data are published.
- Confirmation of efficacy and safety in a single indication of a biosimilar is sufficient for extrapolation to other diseases for which the bio-originator has been approved.
- Currently available evidence indicates that a single switch from a bio-originator to one of its biosimilars is safe and effective. There is no scientific rationale to expect that switching among biosimilars of the same bio-originator would result in a different clinical outcome; however, patient perspectives must be considered.
- Biosimilars should be assessed in registries when multiple switches are made between biosimilars and their bio-originators or other biosimilars.
- Switching to or among biosimilars should not be done without informing the patient and their healthcare provider.
According to the task force, a rapidly growing body of evidence has accumulated that has begun to reduce uncertainty regarding the use of biosimilars for the treatment of rheumatologic diseases. The assembled group of experts and patients expressed confidence that biosimilars approved by the authorities in a highly regulated area are not likely to differ from their bio-originators in clinically significant ways. The cost savings potential associated with the use of biosimilars is another key consideration among clinicians.
- Kay J, Schoels MM, Dörner T, et al. Task Force on the Use of Biosimilars to Treat Rheumatological Diseases. Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases [published online September 2, 2017]. Ann Rheum Dis. doi: 10.1136/annrheumdis-2017-211937