On 28 November 2016, the Italian Chamber of Deputies approved the Draft Budgetary Law of 2017. Among other things, the Draft Law introduces new rules on the substitutability of biologics and the procurement of biosimilars.
In particular, Article 59(11) of the Draft Law provides that:
- two products enjoy a biosimilarity relationship only where this has been established by the European Medicines Agency (EMA) or the Italian Medicines Agency (AIFA);
- the automatic substitution of an originator biologic with its biosimilars (and between biosimilars) is not allowed;