Biosimilari

This article includes (i) a systematic review of the literature on economic issues regarding off-patent bio-drugs market, and (ii) scenarios for biosimilars in Italy. This issue is particularly important, because a growing share of new drugs is derived from biotechnology, patent protections of many of these are expiring and competition on the off-patent market should be promoted to pay for new and innovative drugs. Literature review is focused on the main differences between drugs derived from chemical synthesis and bio-drugs, as for research and development, production, immunogenicity and its impact on post-marketing studies, regulation (marketing authorisation, pricing, interchangeability) and market structure. Estimates on the impact of biosimilars on the Italian market rely on the literature review. Hypotheses on biosimilars’ market penetration and price competition from other models have been adapted to the Italian context. These models consider peculiarities of biologics compared to traditional drugs, including a more conservative approach by clinicians due to uncertainty on the risk profile of new biologics launched into the market. In 2020 savings from biosimilars could range from euro 445 millions (11% of the relevant market) to 575 (14% of the relevant market). The difference between these two scenarios is mostly due to different hypotheses on market penetration and price competition and to the development of biosimilars for monoclonal antibodies.