New Biosimilar Switching Paper Prioritizes Physician-Patient Relationship and Robust Pharmacovigilance

By Brian Kennedy, Executive Director, Global Alliance for Patient Access

A new position paper from the European Crohn’s and Colitis Organisation has garnered attention from physicians and patient advocates across Europe. The paper supports switching inflammatory bowel disease patients from an infliximab biologic medicine to a biosimilar – a position that some readers have misinterpreted as an endorsement for switching all patients to biosimilars.

Clarifying the group’s meaning is important. In debating this point, however, we cannot overlook the paper’s other pertinent arguments, specifically what factors should inform treatment decisions. These bear repeating, and they include:

  • The importance of shared decision-making between health care professionals and patients.

The paper notes that switching should require “appropriate discussion between physicians, nurses, pharmacists, and patients.” It goes on to emphasize that “the decision to initiate a biologic, biosimilar, or non-medical biosimilar switch, should always take into account patient preference.”

European patients and physicians attending GAfPA programs have repeatedly asserted that decisions about switching belong with the treating physician and his or her patient – particularly those who have fought hard to become stable on a treatment.

  • Concerns about multiple and cross-switching among biosimilars. The paper states that “studies of switching can provide valuable evidence for safety and efficacy.” However, it also warns that “scientific and clinical evidence is lacking regarding reverse switching, multiple switching, and cross-switching among biosimilars in IBD patients.”

As noted in GAfPA’s white paper regarding the Norswitch study, the effects of multiple switches have not yet been demonstrated. It is crucial that strong data inform policy and underpin the safe use of biosimilars.

  • The need for robust pharmacovigilance, made possible by adequate tracking and tracing systems. The European Crohn’s and Colitis Organisation paper rightly reinforces the view that all biologics – including biosimilars – should be subject to adequate tracking and tracing in the case of adverse events.

In GAfPA workshops across Europe, physicians and patient advocates have shared the view that robust pharmacovigilance frameworks must be put in place to ensure the safe use of biosimilars. The subject arose most recently at a roundtable on biologics and biosimilars in the UK parliament that GAfPA attended.

In sum: yes, this paper marks a shift in perspective from the organization’s previous publications on biosimilars. And, yes, it does endorse switching from the originator biologic to a biosimilar in patients with inflammatory bowel disease. Yet it also reiterates fundamental ideas about the need for data-driven policies, strong patient safety provisions, and health care decisions driven by patients and their physicians.

Let’s not overlook these points.