European oncologists have had high exposure to biosimilars compared with other European specialists owing to the availability of epoetin alfa and filgrastim biosimilars. Although no biosimilars are available in the United States, we expect the first biosimilar that launches in the country to be Sandoz’s filgrastim, which was accepted for filing by the FDA in July 2014. While the arrival of biosimilars in the market will be a landmark event, a significantly greater commercial opportunity lies in the development of biosimilar monoclonal antibodies (MAbs). Roche’s hugely successful portfolio of MAbs provides a highly attractive target for biosimilar developers, and, unsurprisingly, the pipeline is rich with biosimilar rituximab, trastuzumab, and bevacizumab projects. Nevertheless, a major threat to biosimilar developers is the advent of new, improved biologics, which could supersede current standards of care, thereby reducing the opportunity available to biosimilar versions of currently prescribed biologics. We surveyed oncologists in the United States and Europe to gain insight into key topics such as perception of similarity between biosimilars and reference brands, influence of biosimilar price on uptake, current and future expectations for biologic reimbursement, automatic substitution, indication extrapolation, and their willingness to use next-generation biologics. Our primary research helps inform our market forecasts for biosimilars in oncology across the seven major pharmaceutical markets.
Questions Answered in This Report:
- The prescribing decisions that oncologists make will be fundamental to the uptake of biosimilars in the seven major markets under study; key factors that will drive their decisions are their comfort and familiarity with biosimilars and their level of concern about similarity to the originator product. How familiar with biosimilars are oncologists, and how similar do they think biosimilars are to the reference product?
- In the United States, pharmacists will be able to substitute a reference brand for an “interchangeable” biosimilar, although physicians will retain the option of preventing the substitution in writing or verbally. In France, pharmacists will be allowed to substitute a reference brand for a biosimilar in biologic-naive patients, but physicians can block substitution. Do physicians expect to prevent pharmacists from substituting reference brands for biosimilars in this way?
- Several filgrastim and epoetin alfa biosimilars are available in Europe, but all have been developed according to regulatory guidance designed to demonstrate that they are clinically comparable to the reference brands. Do current prescribers of biosimilars have a preferred biosimilar product and, if so, what drives that preference? How do surveyed U.S. and European oncologists expect to differentiate between multiple biosimilars of the same reference brand in future?
- Roche has numerous strategies in place to defend its HER2 and CD20 franchises’ revenue, including the development of subcutaneous reformulations of Herceptin and MabThera and development of follow-on agents such as Gazyva and Perjeta. Do surveyed oncologists expect to use subcutaneous reformulations if biosimilars are available, and would their opinion be affected by price? Do physicians expect to use trastuzumab biosimilars in combination with other HER2-targeted agents, such as Perjeta, without supporting clinical evidence of efficacy?
Markets covered: United States, EU5, Japan.
Primary research: Quantitative 45-minute online survey of 93 medical oncologists and 89 hematologist-oncologists from the United States, France, and Germany.