BioWorld International Correspondent

BRUSSELS, Belgium - The European biopharmaceutical industry gave a formal welcome to new French controls on biosimilars - generic versions of biotechnology medicines. The new French medicines law, adopted by the French parliament on Feb. 6, prohibits automatic substitution of one biological medicine for another. This is seen by European biotech firms as valuable recognition of the unique nature of biosimilars.

The law states that biosimilars cannot be classified as "generics" in the same way that chemical compounds, because of differences linked to the variability of the active substance and the manufacturing process. The new law also notes that marketing authorization of a biosimilar will require pre-clinical and clinical data. The French senate's public health committee said that biotech reference products and biosimilar medicines are not identical.

Carlo Incerti, president of European Biopharmaceutical Enterprises, the Brussels-based trade association, said: "France is to be congratulated on striking that delicate balance between regulating biosimilars and showing necessary precaution in the protection of patient safety."

He insisted that "a major concern when using biotech medicines is patient safety and drug efficacy. 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. France really serves as an example for other countries."