France's new medicines' law welcomed

The transposition into French law of European Directive 2004/27/EC, the Community's code on human medicinal products, has been welcomed by the European biopharmaceutical industry's trade association, the European Biopharmaceutical Enterprises. Of particular interest to the EBE is that the "law recognizes the unique nature of biosimilars and does not allow automatic substitution of one biological medicine for another."

Carlo Incerti, the EBE's president, said that, "France is to be congratulated on striking that delicate balance between regulating biosimilars and showing necessary precaution in the protection of patient safety."

Among the new law's significant elements are the requirement of preclinical and clinical data for the marketing approval of a biosimilar drug. The EBE also highlighted the specific mention by the French Senate's Public Health Committee as a rationale for the decision, "because biotechnology reference products and biosimilar medicines are not identical, application of the precautionary principle requires that automatic substitution without the consent of the treating physician should not be allowed."