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Our scope of action

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ANSM’s scope of action covers the different categories of medicines (proprietary, generic, biosimilar, herbal, homoeopathic medicines, etc.) available on the market for adults and the paediatric population.

In the development of a medicine, ANSM is involved from the clinical trial phase. It subsequently grants, on a national level, a marketing authorisation (MA) based on the assessment of the benefits and risks of the medicine, and continues to conduct surveillance of its safety of use. Finally, ANSM has control over the advertising for these health products aimed at the public and healthcare professionals.

In the pages below, you will find definitions and general information on the different types of medicines, apart from  vaccines, which are covered in their own separate section.
 

Biosimilar medicines

What are biosimilar medicines ?

A biosimilar medicine is similar to a reference biological medicine which has been authorised in Europe for more than 8 years, and for which the patent has entered the public domain.
Biological medicinal products or biomedicines are obtained using a biotechnological process involving a biological source (proteins, cells, etc.).

A biosimilar medicine is not a generic medicine

Biosimilar medicines and generic medicines are not comparable :
  • the starting material used, production processes, modes of action, marketing authorisation procedures are different;
  • biological reactions result in products which must be closely monitored to ensure similarity between the biosimilar medicine and the reference biomedicine.

What is interchangeability ?

Interchangeability is a medical activity which consists, on the prescriber’s initiative, of replacing a biological medicine by another similar medicine.
It may occur at any time during treatment.
It must be justified and account for the patient’s interests. The following three conditions must be met :
  • inform the patient and receive their consent;
  • provide appropriate clinical monitoring during treatment;
  • provide traceability of the products in question (the prescribe product must be recorded int he patient’s file).