REFERENCE BIOLOGICAL MEDICINES (‘ORIGINATORS’) AND ‘BIOSIMILARS’: COMPETITION AND PATIENT PROTECTION

Abstract

Biological and, especially, biotechnological medicines are some of the most relevant pharmaceutical innovations both for their influence on the treatment of many conditions and because they led the way to devising new and innovative pharmacological therapies. On the other hand, biosimilars, which can be authorized on the date of expiry of the biological originator's patent, give an opportunity for the sustainability of the National Healthcare Service. Following a heated debate in legal doctrine and jurisprudence on biosimilars and automatic substitutability between biological and biosimilar, on the purchasing process of such medicines, and also on the imperative physician's freedom of prescription - intended as framework for patient protection - the 2017 Budget Law has been adopted. This Law encourages the spread of biosimilar products, which is pivotal in making economically viable the use of next-generation medicines in hospitals. It also sets some principles for the definition of the regulatory framework, giving always priority to the physician's freedom of prescription and to any patient's safety and protection.