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Multidisciplinary task force releases consensus document on biosimilars
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While several national and international medical subspecialty organizations have demonstrated conflicting views on the use of biosimilars for inflammatory diseases, an increasing body of evidence has mitigated the reservations around these medications, according to a recently published consensus document.
To achieve this consensus, an expert group of multidisciplinary specialists gathered from eight European countries, Japan and the United States and identified four key topics on the topic of biosimilars that warranted further discussion. They used a Delphi process to develop specific questions to inform a systematic literature review and systematically consulted the Medline database for appropriate English-language publications up to November 2016. Researchers also searched for data on biosimilars among abstracts presented at the American College of Rheumatology and the European League Against Rheumatism annual meetings.
Through the initial search, 490 references to biosimilars were identified. Twenty-nine full-text papers were selected for inclusion. Moreover, the task force extracted 20 abstracts from meeting abstract databases. They formulated five overarching principles and eight consensus recommendations. These principles and recommendations addressed key considerations regarding clinical trials, immunogenicity, extrapolation of indications, changing between bio-originators and biosimilars, and between biosimilars.
The overarching principles were as follows:
1. Patients and rheumatologists should collaborate on decision-making when considering treatments for rheumatic diseases.
2. In weighing treatment options, physicians should consider the context of a particular health care system in terms of insurance coverage and access to care.
3. As authorized in a highly regulated setting, a biosimilar is neither better nor worse than its bio-originator in terms of efficacy, and is not inferior in safety to its bio-originator.
4. The collection of post-marketing pharmacovigilance data on biosimilars and bio-originators, including traceability, should be prioritized and achieved through uniform methods.
5. It is essential to properly educate patients and healthcare providers regarding the nature of biosimilars, the approval process, and safety and efficacy.
6. Patients and health care providers should be informed about the nature of biosimilars, the approval process, and safety and efficacy.
The eight consensus recommendations arrived at by the task force were as follows:
1. At the time of the publication of phase III data on a biosimilar, pertinent preclinical and phase I data on that drug should be available.
2. Due to the established equivalency of a biosimilar to its bio-original in terms of physicochemical, functional and pharmacokinetic properties, verifying efficacy and safety in a single indication is adequate to extrapolate to other diseases for which the biosimilar is approved.
3. According to recent evidence, a single switch from a bio-originator to one of its biosimilars is safe and effective. While there is no scientific basis to expect a different clinical outcome from switching among biosimilars of the same bio-originator, the physician should consider the viewpoint of the patient in this matter.
4. Registries should evaluate the effects of multiple switching between biosimilars and bio-originators.
5. Patients and treating health care providers should be made aware of any switch to or among biosimilars before such a change is initiated.
6. Because biosimilars and their bio-originators do not appear to have any clinically significant differences in immunogenicity, there is no need to measure antidrug antibodies to biosimilars in a clinical setting.
7. Treatment with an approved biosimilar can be conducted in the same way as treatment with its bio-originator.
8. For all rheumatic disease patients, access to biosimilars must significantly decrease the cost of treatment and increase access to optimal care.
There was variation in the level of evidence and grade recommendation for each principle/recommendation based on accessible public evidence.
This consensus statement aims to raise awareness about biosimilars and to discuss the key issues that healthcare providers must consider when using biosimilars to treat their patients,” the researchers wrote. “The assembled group of experts and patients achieved a high level of agreement about the evaluation of biosimilars and their use to treat rheumatological diseases.” -by Jennifer Byrne
Disclosure: Please see the full study for a list of relevant disclosures.
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