Authors: Eduardo Mysler, Valderilio Feijó Azevedo, Silvio Danese, Daniel Alvarez, Noriko Iikuni, Beverly Ingram, Markus Mueller & Laurent Peyrin-Biroulet
Abstract
Over time, clinicians have become increasingly comfortable embracing the prescription of biosimilars—highly similar versions of innovator or reference biological agents—for their patients with inflammatory diseases. Although a switch from a reference product to a licensed biosimilar version (or vice versa) is a medical decision robustly supported by the stepwise accumulation of clinical trial evidence concerning comparable safety, immunogenicity, and efficacy between these products, a switch from one biosimilar to another biosimilar of the same reference product, or a cross-switch, is not. Similarity among biosimilars of a reference product is not a regulatory agency concern and therefore is unlikely to be investigated in randomized controlled trials in the foreseeable future. Yet in clinical practice, across a diverse range of patients, the option to cross-switch from one biosimilar to another can and does arise for valid reasons such as convenience or tolerability issues, or driven by third parties (e.g., payers). In the absence of clinical trial data, clinicians must attempt to objectively evaluate the emerging real-world cross-switching evidence within the context of what is known about the science underpinning a designation of biosimilar. That knowledge then needs to be integrated with what clinicians know about their patients and their disease on a case-by-case basis. This review aims to consolidate relevant emerging real-world data and other key information about biosimilar-to-biosimilar cross-switching for prescribing clinicians. In the absence of clear clinical guidelines addressing this topic at present, this review may serve to facilitate discretionary and educated treatment decision making.
Key Points |
As an increasing number of more affordable biosimilars enter the marketplace, the decision to switch a patient’s treatment from one biosimilar to another is emerging as a potential practical option. |
Pre-clinical scientific data underpin the evidence for drug biosimilarity, with most evidence established via the early analytical, non-clinical, and comparative clinical pharmacology steps performed prior to the clinical study component. |
In the absence of data from formal clinical trials comparing several distinct biosimilars of the same reference product, early preliminary real-world evidence warrants evaluation in the context of each patient’s and payers’ circumstances, and the scientific principles supporting the utility of biosimilars. |
Currently, there is a lack of clinical guidelines to address the concept of cross-switching, and this educational paper is intended to contribute to bridging the knowledge gap that otherwise fuels prescriber hesitancy when it comes to cross-switching between biosimilars, to facilitate safe and effective ongoing treatment for patients. |