Biosimilar drugs, largely unknown in France, could make a sensational arrival in our pharmacies by the end of the year. A prospect that worries some, even if biosimilars have already been in the majority in hospitals for several years.
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You’ve probably never heard of them, and yet they could well have taken over our pharmacies by the end of the year. “They” are biosimilar drugs.
Not to be confused: biosimilar drugs and generic drugs
First of all, it is a question of understanding what distinguishes the conventional medicine from the biological medicine, and the generic from the biosimilar. Conventional medications are called “small-scale moleculemolecule » and resulting from chemical reactions. Their active ingredients are all the same from one tablet to the next. When a drug’s patent expires, other companies can copy the formula and produce identical versions of that drug – usually less expensive: this is the generic drug. For their part, biological drugs (or biomedicines) are proteins manufactured by living cells. They are therefore more expensive and complex to manufacture than small molecule drugs.
To make a biomedicine, cells must be programmed to produce a specific protein. This protein is then isolated, purified and put into pharmaceutical form. When the patent of a biomedicine expires, other companies have the possibility of manufacturing and selling copies similar to this so-called “reference” medicine: these are biosimilar medicines. They are similar, but not identical to the reference medicine and are therefore not considered generics. They work with the same protein and have a similar effect, but they have some differences due to the fact that they are living cells and therefore naturally variable. Differences may also be due to production conditions which may vary, which happens when the manufacturers of the reference medicine do not disclose these conditions precisely.
Biomedicines and their biosimilars have a vast field ofapplicationapplicationparticularly in the treatment of cancer, multiple sclerosis, or even rheumatoid arthritis.
A less expensive process for Health Insurance
The advantage of biosimilars lies in their cost, 15 to 30% cheaper than that of reference drugs… hence the government’s intention – presented in the National Health Strategy 2018-2022 – to reach a rate of “80% penetration of biosimilars in their reference market by 2022”. An objective far from being achieved, but brought back to the table with the examination of the draft Social Security budget last November. “Given the potential for significant savings for Health Insurance that biosimilar medicines represent due to the price difference between the reference biological medicine and its biosimilars, it is appropriate to consider new measures to accelerate recourse to biosimilar drugs »we can read in article 25 TER of amendment no. 596.
A position which should lead to the marketing of several biosimilars that can be substituted in pharmacies: there are currently only two of them, although they are already the majority in hospitals, with an effectiveness rate equivalent to that of reference drugs, and very strict supervision.
Which does not prevent certain patient associations from fearing the worst: if he is troubled, “ The patient will no longer take his treatments correctly. He will no longer seek treatment, or even possibly no longer take his treatments at all, without informing his doctor, and this can have severe effects on his health. worries Marianne Rivière, national president of the French Lupus Association and others autoimmune diseasesautoimmune diseases at the microphone of France Info.
The fact remains that, by the end of the year, “new biosimilars may be offered by pharmacistspharmacists as a replacement for the original biomedicine, two years after their marketing”detail The echoes. According to Health Insurance, this measure should ultimately generate savings of up to 100 million euros.
