In many diseases, the use of so-called generics is quite normal. In the therapy of MS, their use is (still) unusual. Because so far most MS drugs were patent-protected and therefore only original preparations were prescribed. This will soon change, as the first generic MS drugs are currently being approved.
Initially, it will affect the active ingredient dimethyl fumarate. So far it has been marketed by the company Biogen under the trade name Tecfidera®. The second active ingredient to follow soon will be fingolimod, previously known under the trade name Gilenya® by Novartis.
Active ingredient and dosage form in generic and original preparation are the same
But first of all, what do we actually understand by a generic? When a pharmaceutical company develops a new drug and brings it to market, this new drug (also known as an original preparation) is protected by a patent for a few years. The patent protection means that a new drug/the original preparation cannot be imitated and marketed by other pharmaceutical companies. The patent protection thus rewards the effort for the research and development of a new drug. Because during this time only the original manufacturer can make money with the new drug – patent protection is therefore also an incentive to develop new and innovative drugs. The patent protection usually lasts for 20 years. However, many years often pass between the submission of a patent and the market approval of the drug, so that after about 10 years in the market an original preparation loses its patent protection and can be “copied” by other companies.
A generic is therefore a copy of a chemically or synthetically produced original preparation, which is practically an identical copy of the already approved original preparation. The generic carries a different name and differs from the original preparation in its packaging, its color and shape and sometimes also with regard to the auxiliary substances used. However, the active ingredient and the dosage form must be identical. So if the original preparation is a tablet, then the generic must also be a tablet.
Central condition “Bioequivalence”
The most important point when considering generics is, however, that they must not or not relevantly differ from the original preparation in how quickly the active ingredient gets into the blood and in what concentration and for how long it remains there. This central condition is called “bioequivalence” and must be proven by the generic manufacturer through studies (which are usually conducted on healthy subjects). The generic manufacturers no longer have to provide their own proof of efficacy. This is why generics can be offered at a significantly lower price and thus relieve the health system. For this reason, the development of generics is welcome.
Generics in chronic diseases
However, the introduction of generic drugs in chronic diseases like MS is not without problems. With the market launch of generics, it will happen that neurologists recommend switching to a generic or prescribing a generic from the start. In addition, pharmacies are obliged to check the doctor’s prescription to see if there are discounted or cheaper alternatives for a drug. Therefore, it can certainly happen that an original preparation that has been used for a long time is replaced by a generic. Specifically, this could mean for MS patients that instead of the original preparation Tecfidera®, a dimethyl fumarate generic is prescribed or dispensed. From a scientific-medical point of view, this is probably unproblematic. However, I can understand that patients are skeptical, especially with chronic diseases, if they suddenly receive a different medication.
Therefore, after the market launch of the first generics in these days, good communication between doctor and patient on the topic is important: A change from an original preparation to a generic or in the future also from one generic to another, should only take place with the consent and knowledge of doctor and patient. If patients receive something different in the pharmacy (e.g. a generic) than what they expect and which they may not trust, they should talk to their neurologist and discuss their concerns. However, it is expected that neurologists and patients will get used to the use of generics in MS – as has already worked before with many other diseases.
