Biosimilars: considerations in light of the Italian legal framework

• Published in: GaBI Journal Vol. 8; no. 1; pp. 5 - 23
• Main Authors: Rafaelli, Enrico Adriano, Massimino, Fausto
• Format: Journal Article
• Language: English
• Published: Generics and Biosimilars Initiative 01.03.2019
• Subjects: Health care industry; Innovations
• ISSN: 2033-6403; 2033-6772
• DOI: 10.5639/gabij.2019.0801.002

Biological and biotechnological medicines are important pharmaceutical innovations due to their influence on the treatment of many conditions and because they have led the way in devising new and innovative pharmacological therapies. In addition, biosimilars, which can be authorized on the date of expiry of a biological originator's patent, give an opportunity for the sustainability of national healthcare services. This paper explores aspects of Italy's 2017 Budget Law that emerged following a heated debate on legal doctrine and jurisprudence about biosimilars, the automatic substitutability between biological and biosimilar products, the purchasing processes of such medicines, and also on physician's freedom of prescription. This Law encourages the widespread adoption and use of biosimilar products, which is pivotal to making these next-generation medicines more economically viable for use in hospitals. It also sets out some principles that define the regulatory framework that always ensures the physician's freedom of prescription is a priority, as is patients' safety and protection. Keywords: Advertising, biosimilars, competition, Italy, public tenders, scientif c information