In early 2018, nine biosimilars received approval from the U.S. Food and Drug Administration, yet just three had reached the market. In Europe, however, 41 biosimilars have been approved, although initial uptake of these agents in both the United States and Europe has been slow and can depend on a healthcare provider’s willingness to promote, prescribe, and use biosimilars in clinical practice. A study published in the Journal of Managed Care & Specialty Pharmacy found that the top barriers to biosimilar uptake are limited biosimilar knowledge, low prescribing comfort, and safety and efficacy concerns.
Researchers performed a systematic literature review of current U.S. and European healthcare provider knowledge, perceptions, and prescribing behaviors of biosimilars. They searched PubMed, EMBASE, and Cochrane Library for terms related to biosimilar agents, survey questionnaires, and education. They excluded articles that focused solely on budget cost analyses; only surveyed patients, non-prescribing nurses, or other non-prescribing healthcare providers; were general biosimilar overviews; or were published in a language other than English.
Two independent reviewers evaluated 158 English-language studies published between January 1, 2014, and March 5, 2018. A total of 20 studies met the inclusion criteria, most of which were published in Europe (n=17). The most frequently surveyed practitioners in the studies were hospital specialists, gastroenterologists, and rheumatologists.
The researchers found that biosimilar prescribing varied widely between countries and practices.
Most physicians perceived biosimilar medicines as second- or third-line treatment options and mainly restricted use to biologic-naïve patients.
A lack of familiarity with these agents resulted in concerns about biosimilar safety, efficacy, extrapolation, and interchangeability.
The majority of surveyed physicians indicated having an incomplete or basic awareness of biosimilar medicines. Hospital-based practitioners had a higher understanding of these agents compared with office-based practitioners.
The researchers said that detailed descriptions of biosimilar education programs were lacking. Practitioners in both the United States and Europe most commonly reported learning through self-instruction and independent guideline and/or journal article. Some also turned to discussion with a colleague, continuing education, and consultation of promotional manufacturer materials.
“Findings from this study indicate that clinicians in the United States and Europe are cautious about biosimilar use and do not predominantly support the use of biosimilars as safe and effective treatment options in patients already receiving bio-originator therapy,” the researchers concluded. They noted that areas of education that are in need clinician-tailored materials include concepts of immunogenicity, extrapolation, and interchangeability.