Natalizumab was approved in 2004 for the treatment of patients with relapsing forms of multiple sclerosis (MS) and in 2008 to treat moderate-to-severe-Crohn’s disease. In July 2022 the Food and drug Administration (FDA) accepted a Biologics License Application (BLA) for a proposed biosimilar to natalizumab being developed to treat relapsing forms of MS including clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive disease in adults, as well as moderately to severely active Crohn disease. Currently there are no natalizumab biosimilars approved in the United States. Findings from the phase 1 and phase 3 Antelope studies (ClinicalTrials.gov NCT04115488) in RRMS patients showed that the biosimilar natalizumab was equivalent to the reference product based on efficacy, safety and immunogenicity. In January 2023 efficacy and safety data for the proposed biosimilar natalizumab (PB006) in patients with RRMS was published. The results of the Antelope Phase 3 Randomized Clinical Trial.
A recent article A place for biosimilars in the changing multiple sclerosis treatment landscape highlights how biosimilar disease-modifying therapies (DMTs) to treat MS could support patient outcomes and induction therapy goals by providing wider access to high-efficacy biologic DMTs and result in healthcare system savings which may be used to improve overall care.
Resources on the landscape and potential impact of biosimilars to treat patients with multiple sclerosis can be found in the resource library