Bioindustry welcomes new French legislation covering biosimilar medicines
The European biotechnology industry represented by EuropaBio welcomes the passing into law of legislation covering biosimilar medicines in France. The French Parliament has adopted legislation that prevents biosimilar medicinal products from being classed as generics and bans the automatic substitution of one biological medicine for another.
The law confirms the EU legal definition of a "biosimilar" medicine and recognises the uniqueness of this new generation of products. It states that they cannot be classified as "generics" in the same way that chemical compounds may be, due to the differences stemming from the variability of the active biotechnological substance and its manufacturing process.
Commenting on the adoption of the new legislation, EuropaBio's Chair of the Healthcare Council, Andrea Rappagliosi said "We strongly appreciate the efforts made by the French government in pursuing a patient-centred vision by promoting innovation in healthcare".
The ban on the automatic substitution of one biological medicine over another reinforces the central role of the physician-patient relationship that is mandatory in order to deliver the most effective treatment to an individual patient when using biotech-derived therapies.
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