Nephrologists and endocrinologists in Europe have had the opportunity to use biosimilar erythropoiesis-stimulating agents (ESAs) and human growth hormone (hGH), respectively, for several years, but the uptake of these biosimilars has varied from country to country, as well as by drug class and manufacturer. New biosimilars (e.g., biosimilar insulin glargine in Europe and biosimilar epoetin alfa in the United States) are nearing the market that could face similarly muted adoption, or be embraced with greater enthusiasm than their predecessors. To understand why the penetration of biosimilars is so variable, we surveyed endocrinologists and nephrologists about their concerns with current biosimilars, the drivers and barriers to uptake, and their willingness to use biosimilars in future. By consolidating our findings from French, German, and U.S. physicians, we are able to draw meaningful conclusions about adoption rates of current and future biosimilars and provide granular brand and biosimilar market forecasts for the United States, Europe, and Japan.

Questions Answered in This Report:

  • The prescribing decisions that endocrinologists and nephrologists 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 endocrinologists and nephrologists, 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 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 brand Eprex. Do current prescribers of epoetin alfa biosimilars have a preferred biosimilar product and if so, what drives that preference? How do surveyed U.S. and European nephrologists and endocrinologists expect to differentiate between multiple biosimilars of the same reference brand in future?

  • The first biosimilar insulin analogue, Eli Lilly/Boehringer Ingelheim’s Abasria (insulin glargine) was approved in Europe in 2014 and is expected to launch in that region in 2015. How willing are surveyed endocrinologists to adopt biosimilar insulin glargine and would their opinions be influenced by price or the availability of a “biobetter” insulin glargine?

Scope:

Markets covered: United States, EU5, Japan.

Primary research: Quantitative 45-minute online survey of 90 nephrologists and 94 endocrinologists from the United States, France, and Germany.

Author(s): Kate Keeping
Anees Malik, M.Pharm, M.Phil.