HTA Quarterly | Spring 2023

Since approval of the first biosimilar in the European Union (EU) in 2006, many European countries have introduced regulations to incentivize biosimilar uptake in order to lower spending on medicines, but the degree of implementation varies across countries. This article looks at the current status of biosimilar uptake, pricing and reimbursement considerations, incentives, and disincentives in the EU-4 (France, Germany, Italy, Spain), and the United Kingdom (UK).

Innovation, innovativeness, novelty: these and many other synonyms exist to describe the same concept linked to the introduction of something new. In Italy, the healthcare system has established its own rules on how to recognize and reward the innovativeness of a medicinal product, but often the outcome does not align with the rules. Here we provide insights into the decision-making process to highlight the approach needed to get the best results.

In addition to a successful access and reimbursement strategy for biosimilars, understanding the regulatory environment and stakeholder incentives will be equally key to unlock biosimilars' potential.