Biosimilars Face Challenges From Providers, Patients, and Policies

In recent paper published in Rheumatology, authors Till Uhlig, MD, and Guro L. Goll, PhD explore some of the remaining barriers to the adoption of biosimilar therapies in Europe. Physician attitudes, patient concerns, and prescribing restrictions on biologic therapies are all identified in the paper as having a role curbing uptake of biosimilars.

The authors point to a Web-based survey of the European Crohn’s and Colitis Organization, a non-profit organization comprising clinicians who treat inflammatory bowel disease, which showed that, while there existed a high level of awareness of biosimilars and their potential advantages in gastroenterology indications, only 24% of respondents pledged their faith in extrapolating a biosimilar’s indications. Furthermore, 61% said that they had little or no confidence in using biosimilars in their clinical practice. Another study (which included US and European respondents) found that only 47% of respondents believed that biosimilars were safe and effective enough for them to feel comfortable to prescribe, while 43% said that they needed more information about biosimilars.

Patients, too, continue to lack adequate education on biosimilars. The authors report that patients have concerns about pharmacovigilance, interchangeability, switching, and substitution, and that these concerns were cause for both skepticism and anxiety about using biosimilars. They also report that the switch to a biosimilar has been associated with the possibility of a nocebo effect, in which negative expectations of a therapy produce detrimental results.

Furthermore, access to biologic therapies varies across European health systems. As Sonia T. Oskouei notes in a recent contribution to The Center for Biosimilars^®, government involvement, reimbursement systems, and tender procurement policies vary by nation. The authors note a correlation between higher socioeconomic status and access to biologics; specifically, 40% of patients with rheumatoid arthritis (RA) in Europe (approximately 320 million patients) face severe restrictions on their access to biologic therapies. These restrictions are primarily financial, administrative, and prescribing-related; in the 36 countries where biologics are reimbursed, clinical criteria regulate which patients may initiate treatment. In 56% of these countries, a Disease Activity Score 28 scale score (DAS28) of 3.2 or higher was a clinical requirement to initiate treatment with biologics. In 61% of these countries, patients were required to have tried more than 1 traditional disease modifying anti-rheumatic drug before being treated with a biologic.

European nations outside the European Union generally had stricter rules for initiating biologics than were recommended by the European League Against Rheumatism (EULAR), the authors note, and in countries with spending limitations, early RA treatment is less likely. Additionally, cost pressure may prevent patients from receiving the most appropriate treatments.

The authors say that European prescribing practices and regulations will need to change in order to take advantage of the opportunity that biosimilar therapies provide in reducing treatment costs while reducing disparities in access to biologics.