New Treatments in Rheumatology: Biosimilars

Purpose of reviewBiosimilar versions of biologic agents have become increasingly available over the past decade. The framework for regulatory approval has been well established in the USA and Europe, and many biosimilars for use in oncology, rheumatology, dermatology, and inflammatory bowel disease treatment have been approved. Although the utilization of biosimilars has led to substantial cost savings in European countries, this has not occurred in the USA.Recent findingsIn this review, we explore several reasons for the limited uptake of biosimilars in the USA. Discounts and rebates to pharmacy benefits managers and patent litigation are major impediments. Furthermore, physicians and patients in the USA continue to express concerns that biosimilars do not have comparable safety and efficacy, despite abundant scientific evidence to the contrary. The Kaiser and Veterans Administration systems have successfully countered these obstacles and achieved dramatic cost savings as a result. The Kaiser experience illustrates the importance of including prescribing physicians as well as patients as stakeholders in the decision to implement use of biosimilars.SummaryHowever, major changes in the operation of the US health system must also occur for the full potential for cost savings to be realized with use of biosimilars as substitutes for our revolutionary but extremely expensive, biologic medications.