With biosimilar infliximab approved in Europe and filed for approval in the United States, rheumatologists and gastroenterologists will soon have the opportunity to prescribe biosimilars to their patients. Understanding the perceptions and expectations of these specialists with regard to biosimilars will be paramount to a biosimilar developer looking to market an immune or infectious disease biologic, particularly because these specialists have to consider the chronic status of their patients and that the biosimilar might be licensed for use in their specialty through indication extrapolation. We conducted primary market research with rheumatologists and gastroenterologists in the United States and Europe to understand their perspectives on biosimilars and their expected adoption rates. Based on our extensive market research, this report also provides highly granular, brand and biosimilar market forecasts for the United States, Europe, and Japan.

Questions Answered in This Report:

  • The prescribing decisions that rheumatologists and gastroenterologists make will be fundamental to the uptake of biosimilars; 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 rheumatologists and gastroenterologists, and how similar do they think biosimilars are to the reference product?

  • In the United States, pharmacists will be able to automatically substitute “interchangeable” biosimilars for the reference brand, although physicians will retain the option of preventing the substitution in writing or verbally. In France, pharmacists will be allowed to substitute a biosimilar for the reference brand in biologic-naïve patients, but physicians can block substitution. Do physicians expect to prevent pharmacists from substituting reference brands for biosimilars in this way?

  • Indication extrapolation allows a biosimilar to be approved for all indications for which the reference brand is approved for, without the need for the biosimilar developer to have performed a clinical trial in each indication. What are physicians’ opinions on indication extrapolation, and do they intend to prescribe in extrapolated indications?

  • With multiple biosimilar developers targeting the same reference brand biologic, the need for a biosimilar developer to positively differentiate its biosimilar will be a key requirement in order to appeal to prescribers and capture patient share in this competitive market place. How will physicians choose between multiple biosimilars of the same reference brand?


Markets covered: United States, EU5, Japan.

Primary research: Quantitative 45-minute online survey of 89 rheumatologists and 95 gastroenterologists from the United States, France, and Germany.

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