11
Feb
A New Regulatory Framework for the Public Procurement of Off-Patent Pharmaceuticals in Italy: Balancing Cost Control and Supply Continuity
Italian law recently established a comprehensive framework governing the public procurement of off-patent non-biological pharmaceuticals for which generic equivalents have been introduced to the market.
25
Feb 25
Procurement of biosimilar medicines in public tenders: Regulatory framework and recent caselaw
The procurement of biosimilars intended for the entities of the National Health Service, while generally regulated by the Public Procurement Code, is subject to special rules due to the unique characteristics of these products compared to chemically derived medicines.
12
Apr 21
The Italian Medicines Agency provides additional information on the new simplified classification procedure for generics and biosimilars
The Italian Drug Agency (AIFA) provided further information on the new simplified pricing and reimbursement procedure introduced in October 2020 for generics and biosimilars.
3
Dec 20
Generic and biosimilar medicines: Italian Medicines Agency adopted a new simplified pricing and reimbursement procedure
On October 15, 2020, the Italian Medicines Agency (Agenzia Italiana del Farmaco – “AIFA”) published a new simplified pricing and reimbursement procedure for generics and biosimilars.
16
Dec 19
Regional Administrative Court of Tuscany: recent judgment on biosimilars
n November 26, 2019, the Regional Administrative Court of Tuscany (Tribunale Amministrativo Regionale – “T.A.R.”, “Court”) ruled on the request for the invalidation of the Regional Council of Tuscany Resolution No. 457/2019 (“Resolution”) concerning the procedures for the supply and use of biosimilars in Tuscany.
3
Apr 19
Italian administrative court judgments on biosimilars
In the past two months, the Italian administrative courts issued two judgments on biosimilars that substantially confirmed the previous case law on the relevant subjects.
