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Gaining Confidence With a Switching Study


Sonia T. Oskouei, PharmD, BCMAS, DPLA, navigates the impact of the VOLTAIRE-X study, the only published switching study for adalimumab, on biosimilar uptake.

Sonia T. Oskouei, PharmD, BCMAS, DPLA: The VOLTAIRE-X study is significant because it represents the first randomized clinical trial to assess outcomes with a monoclonal antibody that was structured to meet the FDA’s requirements based on the draft guidance for interchangeability designation. In the draft guidance, the FDA recommends conducting a switching study, where you switch back and forth 3 times between the originated biologic and biosimilar to prove that there aren’t any differences in outcomes. The VOLTAIRE-X study was the first of its kind to do this with a monoclonal antibody.

This study was a phase 3 interchangeability study with the US-marketed original formulation of Humira [adalimumab]. It aimed to assess whether multiple switches between the originator product and biosimilar led to equivalent pharmacokinetics and a similar safety and immunogenicity profile compared with continuous adalimumab use, the originator product, in patients with moderate to severe chronic plaque psoriasis. At week 32, the study met its primary end points and demonstrated that there was pharmacokinetic equivalence with highly similar efficacy and immunogenicity and comparable safety in patients who received the originator product continuously or were in the switching arm. These findings ultimately support the interchangeability of Cyltezo through the FDA.

The importance and the essential value of having this study completed, especially ahead of 2023, is the availability of desired data. Market research continues to reveal that clinician hesitation remains among providers, particularly in the immunology space, and with greater hesitation in switching scenarios. Any additional data and evidence that can strengthen clinical confidence and biosimilar utilization, especially in those switching scenarios, is very important.

Immunology conditions, such as rheumatoid arthritis or GI [gastrointestinal] conditions, are often chronic, and patients require long-term treatment. There’s significant opportunity with biosimilars, especially in the immunology space, to enhance patient affordability and accessibility of high-quality treatments. The opportunity must be available for all patients in their treatment journey: new starts, if a patient was recently diagnosed and is initiating therapy, and for patients who are on existing originator biologics. Hence, switching data are important to have to support the latter scenario for patients who may potentially benefit from a lower-cost high-quality treatment.

Given the pipeline of activities, we’re expected to see even more growth in these switching studies with additional biosimilar candidates, which will strengthen the overall clinical confidence in various scenarios with biosimilars.

Transcript edited for clarity.

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