European biopharma industry welcomes new French medicinal law
The French Parliament has adopted a new law on medicines, transposing European Directive 2004/27/EC - the Community code on human medicinal products - into French law.
The French Parliament has adopted a new law on medicines, transposing European Directive 2004/27/EC - the Community code on human medicinal products - into French law.
Among other things, the law recognises the unique nature of biosimilars and does not allow automatic substitution of one biological medicine for another. The French Parliament's move to make patient safety paramount has been welcomed by the European biopharmaceutical industry.
The law establishes a legal definition of a 'biosimilar' medicine that recognises the uniqueness of these medicines. It states that they cannot be classified as 'generics' in the same way that chemical compounds may be, due to the differences linked to the variability of the active substance and the manufacturing process.
Furthermore, the new law notes that regulatory approval of a biosimilar medicine will require pre-clinical and clinical data. Crucially, in the Senate's public health committee's report, it is stipulated that because biotech 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.
'France is to be congratulated on striking that delicate balance between regulating biosimilars and showing necessary precaution in the protection of patient safety,' said Dr Carlo Incerti, the President of European Biopharmaceutical Enterprises (EBE).
He also highlighted EBE's support for the requirements in the French law that prohibit the automatic substitution of biotech medicines with biosimilars. 'Because biosimilars are not exact copies of the reference products, they cannot have the exact same safety profile as the original biotech medicine.
'In order for physicians to be able to monitor their patients for any unexpected or adverse immune reactions, it is essential that they retain control over the treatment and therefore important that automatic substitution at the level of the pharmacy is not permitted for biotech, including biosimilar medicines,' he stressed.
The new law, which will be published before 6 March 2007, brings France up to date with all European requirements concerning the granting of marketing authorisations including data protection, the labelling and packaging of medicines, a definition of generic medicines and biosimilar medicines.