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;
- in public tenders for biosimilars, two products with different active substances may not be included in the same procurement lot even where they have the same therapeutic indications. In this regard, the Draft Law also introduces specific rules on how to design public tenders for biologics and their biosimilars.
While the first two points mentioned above constitute a mere codification of the current regulatory practice, the third represents an important novelty. In fact, an Italian administrative court has recently found that it is legitimate to include two originator biologics with equivalent therapeutic indications in the same procurement lot.
The text approved by the Chamber of Deputies is slightly different from the text initially presented by the Government, and takes into account some of the concerns raised by the Italian Competition Authority (AGCM) about the first draft. The AGCM had also expressed concerns about the “rigid exclusion of any possible automatic substitutability between an originator and its biosimilar versions, and between different biosimilar versions of the same originator,” in particular because of possible future developments on biosimilar substitutability. However, this concern was finally not taken on board by the Chamber of Deputies.
The text must now be approved by the Italian Senate before it enters into force. It is noteworthy that the Senate may possibly introduce further changes to the text, in particular in light of the concerns raised by the AGCM and the recent case law on biologics.
The rules on biosimilars introduced in the Budgetary Law of 2017 will also certainly have an influence on the final version of the Concept Paper on Biosimilars that AIFA is expected to publish after the public consultation it carried out last summer (see our blog post here).
The upcoming changes described in this blog post show that biosimilars remain a hot topic in Italy. Companies should carefully monitor future developments in this area.