Clinical and radiological implications of subpotent generic fingolimod in multiple sclerosis: a case series.

ABSTRACT: An expansion in the availability of generic specialty disease modifying therapies (DMTs) for treatment of multiple sclerosis (MS) has increased recently. Generic specialty medications aim to provide greater access to molecules that alter the disease trajectory at lower costs. The US Food and Drug Administration requires generic products to contain between 90% and 110% of the stated active ingredient and an 80%-125% bioequivalence range. We present the clinical experiences and absolute lymphocyte counts (ALC) trends of six people with MS originally treated with Gilenya^® (fingolimod) 0.5 mg who were required to transition to generic fingolimod 0.5 mg by third-party administrators, and the medication content from recovered products. Six individuals with acute clinical exacerbations

SUBMITTER: Okuda DT 

PROVIDER: S-EPMC11580071 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature