Talking to Patients about Biosimilars

Abstract

Biologic therapies target aberrant pathways in diseases including diabetes, cancer and autoimmune disorders. Despite recent scientific advances, patient access to these agents can be limited. Biosimilars are designed to be highly similar to the originator biologic, targeting the same biological pathways, with comparable efficacy and safety. Biosimilars have the advantage of lower treatment costs, offering the potential for increased clinical use and patient access. Several biosimilars are approved for clinical use in the USA and Europe; however, there is a lack of awareness about biosimilars among healthcare providers and patients. This overview of the scientific basis of biosimilars and current indications aim to enhance discussions with patients and increase understanding of the role of biosimilars in individual treatment plans.

Informing Patients about Biosimilar Medicines: The Role of European Patient Associations

“…Yet, an open and positive attitude should be adopted by all healthcare providers (i.e., physicians, nurses, and pharmacists) who communicate with patients. This involves empathy, reassurance, and nonverbal elements in their communication towards patients when discussing medicines in general [51,62]. It will be essential to educate HCPs using these communication techniques or 'soft skills' in the future.…”

Current and future roles of biosimilars in oncology practice (Review)

“…Biosimilars must have the same therapeutic indications, mechanism of action, route of administration, dosage form and strength as the reference product. Some minor differences in clinically inactive components may be allowed, as long as they do not affect the drug safety (10).…”

“…Furthermore, various studies have identified significant gaps in the knowledge of healthcare professionals concerning biosimilars; therefore, it is important to increase awareness and inform professionals that the approval of biosimilars is based on reliable scientific data and clinical trials (14). Both the European Society for Medical Oncology and the American Society of Oncology have developed guidelines to assist healthcare professionals and enhance their confidence in prescribing biosimilars (10). Furthermore, in Australia, a significant effort has been made to alleviate misconceptions regarding biosimilars, with the government spending AU$20 million on this issue (13).…”

“…The World Health Organization recommends that in order to demonstrate biosimilarity between biologics and their respective biosimilars, compatibility and characterization studies must be conducted for comparative evaluation of physicochemical properties, stability, impurities and biological activity (10). Both the FDA and EMA have robust guidelines in order to demonstrate biosimilarity through in vitro and in vivo data (15).…”

“…A study reported that by switching to an erythropoietin biosimilar in patients with chemotherapy-induced anemia, vast savings were accomplished, thus enabling additional treatments with rituximab (9,770 treatments), bevacizumab (3,912 treatments) and trastuzumab (3,713 treatments) (47). Another cost-analysis study in Europe, predicted that switching to a rituximab biosimilar would save €56.82 million over a year (10). However, the cost-saving potential depends on various factors, such as the price of the reference product and the competition market (11).…”