First Biosimilar in the Town for Multiple Sclerosis (MS)

On August 24, 2023, the U.S. FDA approved Tyruko (natalizumab-sztn), the first biosimilar to drug Tysabri (natalizumab) injection for treating adult patients with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also used for inducing and maintaining clinical response and remission in adult individuals with moderately to severely active Crohn’s disease (CD) with evidence of inflammation who have had an inadequate response to or are not able to tolerate, conventional Crohn’s disease therapeutic options and inhibitors of TNF-α (TNF, a substance in the body that causes inflammation).

According to Paul R. Lee, M.D., Ph.D., director of the Division of Neurology 2 in the FDA’s Center for Drug Evaluation and Research, “Biosimilar medicines offer additional promising therapeutic options that have the potential to increase access for individuals living with relapsing forms of multiple sclerosis (MS). This approval could have a significant impact on individuals managing their condition.”

The approval of Tyruko, a biosimilar to Tysabri (natalizumab), is based on evidence that demonstrates there are no clinically meaningful differences between the 2 medicinal products in the context of safety, potency, and purity(i.e., safety and effectiveness).

The Food and Drug Administration granted approval for the drug Tyruko, the first biosimilar to Tysabri (natalizumab), to Sandoz Inc.

About Multiple Sclerosis (MS):

Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disorder of the central nervous system (CNS) that disrupts communication between the brain and other organs of the body. It is among the most common causes of acquired neurological disability in young adults and occurs more frequently in females than males. For most individuals with multiple sclerosis, episodes of worsening function and the occurrence of new symptoms, named relapses, are initially followed by remissions (recovery periods). Over time, recovery may not be complete, leading to a progressive decline in function and enhanced disability.

Reference:

https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-multiple-sclerosis