Abstract: Biosimilars are hypothesized to contribute to lowering health care costs by entering the market at a discounted price compared with their reference biologics. Until recently, only filgrastim biosimilars were available in oncology, but bevacizumab and trastuzumab biosimilars have now been approved, and additional biosimilars are expected to enter the oncology landscape as more biologics lose their patents and market exclusivity. However, biosimilars uptake and commercial success is contingent upon prescribers’ acceptance of their safety and efficacy as well as prescribers’ understanding of the regulatory processes that lead to biosimilars’ approval. Identifying barriers to uptake is essential to develop strategies that increase chances of biosimilars’ success in oncology. To that end, we conducted primary market research study of over 500 US-based hematologists and oncologists. A survey was administered that included questions about reimbursement, regulatory guidelines, and the use of specific biosimilars. Based on the responses, we identified critical educational gaps that need to be addressed by manufacturers and policymakers in order for biosimilars to achieve their potential for lowering the cost of cancer care in the United States.
Acknowledgments: This research was presented in part as a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual Meeting in Boston, MA, May 2017.
Biosimilars are biological medicines that contain a highly similar version of the active substance of an already approved biologic, referred to as the “innovator” or “reference product.”1 Biosimilars have been proposed as one way to lower US health care costs by entering the market at a reduced price.2 To facilitate market entry of biosimilars, the Food and Drug Administration (FDA) has established abbreviated regulatory pathways leading to approval.3 Biosimilars must establish similar quality, safety, efficacy, and immunogenicity characteristics to the innovator, but minimal differences that are not clinically meaningful are permitted.4 Once similarities are established, the FDA allows at least one of the innovator indications to be listed as an indication to the biosimilar.4 In addition, the FDA allows extrapolation of safety and efficacy data from one biosimilar indication to another after rigorous requirements are fulfilled.5 Regulatory guidelines are designed to assure that biosimilars are safe and effective when used in place of innovators regardless of disease type and stage.6
Until recently, only the biosimilar to filgrastim was approved for use in cancer patients.4 As patents of more biologics expire in the next few years, more biosimilars are expected to enter the US market.2 In fact, biosimilars to bevacizumab (bevacizumab-awwb; Mvasi) and trastuzumab (trastuzumab-dkst; Ogivri) were recently approved by the FDA, and rituximab biosimilars are expected to follow.4 With more biosimilars in queue to get FDA approval, understanding oncology providers’ perceptions of biosimilars’ efficacy, toxicity, and relative cost to value is essential to drive strategies for market uptake.
Physicians’ acceptance and understanding of biosimilars have been questioned. Cohen et al surveyed 1201 physicians of various specialties (ie, dermatology, gastroenterology, hematology/oncology, nephrology, and rheumatology) who were heavy prescribers of biologics.7 The results highlighted a significant need for evidence-based education about biosimilars with a specific focus on regulatory processes, safety, immunogenicity, and extrapolation.
We aimed to better understand community oncologists’ general biosimilars understanding and perception of barriers to biosimilars acceptance. We did so by conducting surveys of physicians during live meetings that focused on the topic. The aim was to identify challenges that might hinder community oncologists’ use of biosimilars in oncology in order to determine appropriate responses to address these challenges. The future success of biosimilars in the US oncology market will heavily depend on oncologists’ acceptance of these agents and on payers considering biosimilars as the preferred medicines when possible.
Between November 2015 and November 2017, a total of 510 US-based community oncologists/hematologists and practice administrators were surveyed during 8 live regional conference meetings to assess their knowledge of biosimilars and perceived barriers to their adoption.
Participants were chosen from meeting attendee lists. The practice administrators who were selected to participate in this study were those who were primarily involved in purchasing biologics and/or biosimilars for their respective practices and were representative of the prescribing patterns and acceptance of their own physicians about biosimilars.
The 25-question survey was created de-novo by the authors and included questions on respondent demographics, type of practice, practice location, and detailed questions related to biosimilars. The survey included multiple choice answers to specific questions when necessary. Audience response system devices were used to capture participants’ responses and allowed more than one answer selection when appropriate. The accompanying data tables in this article represent a selection of 13 of the 25 survey questions that had the highest number of responses; tables are separated based on 3 distinct aspects of biosimilars.
During survey administration at these live meetings, follow-up discussions sometimes took place after answers for some questions were submitted. These discussions were not easy to capture; pre- and post-discussion questions and answers were not used. The answers as presented in this research report are what was generated from this market research study.
The numbers and percentages cited below are the collective data (N = 510) for all respondents from the 8 live meetings. It should be noted, though, that not all questions were asked in each of the meetings, and not every respondent answered all questions, therefore, there was a variability in the number of respondents for each question.
Respondents represented a variety of practice types: large size (> 10 physicians: 20%), medium size (6-10 physicians: 15%), small size (2-5 physicians: 17%), solo practice (15%), hospital-owned community practices (16%), community-based hospitals (5%), and university-owned hospitals (11%). Participants represented all geographic areas in the United States: (38% South, 26% Midwest, 17% Northeast, and 19% West).
When asked about their general familiarity with biosimilars, 79% physicians (239 of 302 respondents) stated they are very or somewhat familiar. Almost all physicians (92%; 58 of 63 respondents) said they are aware of the 3 currently approved biosimilars with oncologic indications, and 65% of the physicians (126 of 196 respondents) stated they had prescribed a biosimilar at some point in the preceding 12 months. Also, 62% (24 of 39 respondents) suggested that they are aware of 2 to 4 biosimilars that are currently under development, although this perception was not necessarily supported with cited data.
Almost 95% of surveyed physicians (38 of 40 respondents) were very or somewhat confident that biosimilars are as safe and effective as their reference biologics. This level of confidence translated into how oncologists plan on prescribing currently available biosimilars, soon-to-be-available biosimilars, and biosimilars that are likely to be approved in various disease settings (Table 1). Most oncologists felt that prescribing biosimilars is suitable whether the goal is cure or disease control.