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).