For some time now, the patent protection for the multiple sclerosis (MS) drug Gilenya® (Fingolimod) has expired – the active ingredient Fingolimod can therefore now be marketed as a generic drug.
Fingolimod, a sphingosin-1 receptor agonist, is considered an effective treatment for multiple sclerosis (MS) and, as the first oral MS therapeutic, was widely used in the past. I wrote a blog post about generics in MS therapy some time ago and expressed understanding that MS patients may be uncertain about switching to a generic drug, especially if they have benefited from a drug in the past.
Scientifically speaking, there is nothing against switching to a generic drug, as generics contain the same active ingredient in the same strength and dosage form and must prove their equivalence to the original through bioequivalence studies. Bioequivalence means that the active ingredient from the generic drug and the original preparation reaches the bloodstream at comparable speed and quantity, with the values having to be within set limits. Therefore, I see the use of generics in (neuro-) immunological diseases – unlike in epilepsy, where the exact blood levels are more important – as basically uncritical. Also against the background that the use of generics saves our health system money.
Original or generic?
In February 2026, a study was published in the MS Journal (Patel MA et al. Mult Scler. 2026 Feb;32(2):192-201) observing an increased relapse activity after switching to generic Fingolimod, even though the disease had been stable for a longer period before. Methodologically, retrospective data from a specialized MS center were evaluated. The time until the occurrence of MRI activity as well as the time until a clinical relapse during treatment with Gilenya® or generic Fingolimod was investigated. In addition, differences in the absolute lymphocyte count (ALC) and side effects between the treatment groups were recorded. The cohort consisted of 88 MS patients (71 female; mean age at start of Gilenya® therapy: 39.6 years; mean age at start of therapy with generic Fingolimod: 46.9 years.) A shorter period until MRI activity (p = 0.0026) as well as until the occurrence of a relapse (p = 0.0027) was observed under the treatment with generic Fingolimod. The absolute lymphocyte count increased by 8.81% under generic Fingolimod compared to Gilenya®. In addition, a 2.45-fold and thus significant increase in side effects was observed under generic Fingolimod compared to Gilenya® (p = 0.002). According to the results of this study, the efficacy and side effect profile of generic Fingolimod would therefore be worse.
Even though the results of this study must be taken into account, they cannot be left uncommented. Firstly, 88 patients is a rather manageable number, on the basis of which no definitive statements can be made. Another point of criticism is that it is an open study, so the patients knew that they were being switched from a patent-protected preparation to the generic. Therefore, it is conceivable that some clinical findings on efficacy and side effects, which were collected in the study, could also be explained with the above-mentioned uncertainty after switching to a new concept. In any case, a certain bias cannot be ruled out due to the study design. And finally, it must be acknowledged that the effect of the preparations was compared in different stages of the disease due to the sequential switching of patients.
My conclusion is therefore that no judgment can be made about the effects of generics on neuroimmunological diseases based on this study. The frequently practiced switch to generics in MS is not called into question by the current study.
This post was translated from German to English with the help of AI.
