Appropriate Steps Needed for Integration of Biosimilars in MS Treatment Paradigm: Barry Singer, MD
The director and founder of The MS Center for Innovations in Care provided thoughts on the potential role of biosimilars in treating multiple sclerosis and the steps needed to ensure that this integration process is safe. [WATCH TIME: 4 minutes]
WATCH TIME: 4 minutes
"Typically, biosimilars are about 30% less in cost, and that’s a huge factor as we go forward. Many parts of the world do not have high-efficacy therapy available. They may use off-label rituximab. Having a biosimilar could provide more access to high efficacy therapy around the globe."
Over the past 2 decades, the clinical community has witnessed immense development of high-efficacy disease-modifying therapies (DMTs) for relapsing forms of multiple sclerosis (MS). Clinicians who treat such patients now have a wide range of options at their disposal, each with various mechanisms of action, administrations, costs, and adverse event (AE) profiles.
Earlier this year, the FDA approved Sandoz’s and Polpharma Biologics’ injection treatment natalizumab-sztn (Tyruko), the first biosimilar to the approved formulation of natalizumab (Tysabri; Biogen) for the treatment of adults with relapsing forms of MS. Biosimilars require a specialized process with the FDA, must be nearly identical to the original biologics, and are typically less expensive than the original form.
Biosimilars, like the originator biologics, will have natural differences from batch to batch because they are made from living sources; however, this is not an issue as long as the slight variations fall within acceptable, predefined limits by FDA standards. At MSMilan 2023, the joint ECTRIMS-ACTRIMS meeting, held October 11-13, in Milan, Italy, NeurologyLive® sat down with MS expert Barry Singer, MD, to discuss the era of biosimilars, and the steps needed to properly integrate them into clinical care.
Singer, director and founder of The MS Center for Innovations in Care, spoke on the required process for these agents, importance of education, and the potential they offer. Additionally, he provided in depth analysis of certain pharmacokinetic parameters that need to be checked off before a biosimilar is approved.
