REGULATORY: Italian framework on public procedures for the purchase of biological medicinal products Biosimilarity and bioequivalence in Italian law


Avv. Sonia Selletti

Avv. Annalisa Scalia

Studio Legale Astolfi e Associati Law Firm
Milan, Italy

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The increasing development of biological medicinal products recorded in recent years has been an incentive for competition on the market. It has also stimulated the scientific community and regulatory bodies to discuss about how to reconcile therapeutic innovation with the containment of public pharmaceutical spending.

In this context, in Italy, the same system used for the supply of chemically-derived medicinal products has been used for the procurement of biological products, i.e. invitations to tender for a single lot, “grouping” (sometimes in the same lot) not just originator drugs and their biosimilar counterparts, but also biological medicinal products containing different active principles but that are considered therapeutically equivalent.

As a result, a number of delicate applicative issues have arisen and, to date, many have not been solved ... ...