Advocacy Group Calls for Congressional Oversight Hearings on Biosimilars

Patients for Biologics Safety and Access (PBSA), a coalition of patient advocacy organizations, called on the US Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce to convene oversight hearings on biosimilar medicines.

The group hopes to ensure that the interests of patients are protected as biosimilars begin to enter the US marketplace. In its request to Congress, PBSA asks lawmakers to take steps to “protect people from harmful insurance practices,” including the nonmedical switching of non-interchangeable biosimilars.

In a statement, Larry LaMotte, vice president of public policy at the Immune Deficiency Foundation and lead coordinator of PBSA, said, “As more biosimilars come to market, it is critical that Congress ensure that the FDA is prioritizing patient safety through its guidance, approvals, education and post-market surveillance.”

Nonmedical switching has come under greater scrutiny as health systems—particularly in Europe—switch patients from reference biologics to biosimilars for the purpose of reducing healthcare costs.

At the 2017 American College of Rheumatology (ACR)'s Annual Meeting in San Diego, California, researchers presented findings on a nationwide nonmedical switch of all patients in Denmark who were taking brand-name Enbrel to a biosimilar etanercept, the European-approved Benepali. While 89% of the patients who were transitioned experienced the switch as an uncomplicated continuation of treatment, 11% stopped using the biosimilar after a 4-month follow-up due to either a significant loss of treatment efficacy or adverse events (AEs).

A second study, also presented at the ACR meeting, showed that a non-mandatory, nonmedical switching program in The Netherlands, which included patients with rheumatoid arthritis, found that patients who transitioned to Benepali from Enbrel had a significantly higher relative risk of discontinuing therapy than patients who remained on the originator drug.

However, other research has pointed to the so-called “nocebo” effect (a phenomenon that occurs when a patient’s negative expectation causes a treatment to have a more negative effect than it otherwise would) as a potential explanation for such results; in switching studies in which both patients and physicians are masked as to who is taking a biosimilar rather than an originator biologic, transitioning to a biosimilar is no different with regard to safety and efficacy than continuing the original therapy without interruption, a finding that suggests that the ways in which information about biosimilars is communicated to patients has a key role in successful nonmedical switching.

In addition to its concerns about nonmedical switching of biosimilars, PBSA has asked Congress for an evaluation of postmarketing surveillance activities to ensure that all products—whether biosimilar or innovator—are adequately tracked for AEs, and also called for greater efforts to educate patients and providers on the introduction of biosimilars into the marketplace.