A multidisciplinary task force has recommended pharmacologic therapy using biosimilars vs bio-originators for the treatment of rheumatological diseases, A set of 5 overarching principles and 8 consensus recommendations, based on expert opinion and research evidence from a systematic literature review, were published in Annals of the Rheumatic Diseases.
The task force found little existing information and guidance in the literature aimed at helping clinicians understand and evaluate biosimilar options, and felt an international consensus would aid physicians and patients in their decision making. The overarching principles and consensus recommendations in the statement were intended to serve not only as clinical guidance but also as scaffolding for further educational efforts. There were multiple foci considered during this process: clinical trials, indication extrapolation, immunogenicity, cost, and switching from bio-originators to biosimilars, as well as among various biosimilars.
The systematic literature review examined relevant publications through 2016 using Medline, in addition to American College of Rheumatology and European League Against Rheumatism conference abstracts from 2015 and 2016. Of 490 publications identified, 29 papers were included in the assessment, along with 20 conference abstracts. Based on voting results, principles and recommendations that received ≥80% expert agreement were incorporated into the final declaration.
The 5 overarching principles, along with the level of agreement for each, are presented here:
- Patients and rheumatologists should decide jointly on a treatment course for rheumatic diseases. (100%)
- Treatment decisions should consider the context of the specific healthcare system to increase affordability and therapeutic access. (100%)
- A biosimilar should have equivalent efficacy to its bio-originator and should not have an inferior safety profile. (88%)
- Clinicians and patients should understand the basics of biosimilars; specifically, their safety, efficacy, and approval process. (96%)
- Pharmacovigilance data, particularly traceability, should be sought for biosimilars and bio-originators via harmonized methodology. (100%)
The 8 consensus recommendations, followed by level of agreement, were:
- Biosmiliar availability must substantially reduce patient costs while improving access to the best therapy for all patients. (100%)
- Biosimilars approved for use may be employed in the same fashion as their bio-originators in terms of patient therapy. (100%)
- There is no need to measure antidrug antibodies for biosimilars, based on the lack of detected differences between biosimilars and bio-originators in terms of immunogenicity. (100%)
- Once phase 3 data become available, phase 1 and preclinical information should be published as well. (100%)
- Proof of safety and efficacy of a biosimilar for 1 indication should permit extrapolation to other conditions for which the bio-originator has been approved, based on established pharmacologic equivalency between the 2. (100%)
- Although patient viewpoints must be considered, there is no reason to believe that switching among various biosimilar agents of a single bio-originator will present varied outcomes, based on evidence available regarding a single switch from bio-originator to biosimilar. (96%)
- When considering multiple switching between bio-originator and biosimilar, or among various biosimilars, clinicians should consult health registries. (100%)
- Patients and clinicians should be aware of proposed therapeutic changes before switching from bio-originators to biosimilars or among various biosimilars. (91%)
The information contained here is primarily concerned with improving access to these medications via a shift to less expensive forms; namely, biosimilars. After consultation between physician and patient, the latter should be placed on an appropriate biosimilar that is equivalent to the bio-originator in safety and efficacy, so that patient costs are reduced for as much of the population as possible. The ultimate goal is increased availability of effective therapies used to combat inflammatory disorders.
Kay J, Schoels MM, Dörner T, et al; on behalf of the Task Force on the Use of Biosimilars to Treat Rheumatological Diseases. Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis. 2017;77(2):165-174..