FRI0126 Patients’ concerns about and perception of biosimilars in rheumatology : a french survey

Frantzen, Léa; Cohen, Jean-David; Sonia, Tropé; Beck, M.; Diebold, R.; Sittler, Marie-Annick; Munos, Audrey; Arnaud, Laurent; Gottenberg, Jacques Éric; Sibilia, Jean; Afif, N.; Sordet, Christelle

doi:10.1136/annrheumdis-2018-eular.4888

Cited by 2 publications

(1 citation statement)

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“…The perspective of prescribers has significantly evolved over the last couple of years. When the first anti-TNF biosimilars were developed in RA and ankylosing spondylitis, many gastroenterologists were very reluctant to extrapolate clinical data obtained in rheumatology and prescribe these biosimilars to patients with Inflammatory Bowel Disease (IBD) [15]. The European Crohn's and Colitis Organization (ECCO) actually stated that, "switching from an established biologic to a biosimilar to save costs is likely to be as inappropriate and ineffective as switching between current biologics that act on the same target, except when there is loss of response [16]. "…”

Section: Clinician's Perspectivementioning

confidence: 99%

Biosimilars: Patient Perspectives, Challenges and Emerging Solutions: Current Opinions

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2019

J Drug Res Dev

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Current evidence suggests that while most patients have a limited understanding of the risks and benefits of biosimilars, they generally trust their physician to prescribe the right compound. Unfortunately, training and education programs on biosimilars targeting prescribers have had a limited reach. Most physicians believe that so-called reference compounds are cast-in-stone, and are not aware of the evolution of the manufacturing process of many of these reference compounds. Physicians are rarely aware of the product that will be delivered by the hospital pharmacists, and, despite their legal obligations, do not necessarily have the time to discuss the reasons for the prescription of a biosimilar product with their patients.Yet, analytical methods have enabled a detailed and precise profiling of biosimilars, as well as a better understanding of the relationship between the structure and function of proteins, rendering large phase-3 trials no longer necessary. Indeed, phase-3 trials have failed to show any meaningful, clinical difference between originator and biosimilars, when analytical similarity was established. Regulators have also significantly evolved, and are becoming more comfortable with the concept of extrapolation of indications. Based on the results in one single indication, products given to oncology patients, such as peg-filgrastim, are now approved in the U.S. and E.U., based on a solid CMC package, and phase-1 trials performed with volunteers, without a single cancer patient enrolled in the clinical program. Hence, significant progress has been recently observed in the field of biosimilars. In order to address the remaining communication challenge, biosimilar companies should with the support of independent scientific and medical societies: (A) significantly invest in the training of medical professionals, including nurses (B) Develop patient information/assistance programs, (C) Partner with patients organizations and regulators, (D) Organize Patient Advisory Boards to ensure the study is feasible and that informed consent forms provide accurate and useful information, and (E) Economically incentivize patients to accept a biosimilars prescription, and (F) Above all, consider patients as partners, and no longer as "subjects". Patients, prescribers, and payers must also accept that biosimilar adoption is the only viable option if public health insurances wish to keep reimbursing therapeutic innovations such as CAR-T and checkpoint inhibitors; all of these actors must realize that biosimilar adoption is, in effect, one of the manifestations of an evolving Social Contract, by which patients accepting the prescription of biosimilars will enable the access to expensive and life-saving biologics to a larger population.

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Section: Clinician's Perspectivementioning

confidence: 99%