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.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.