Abstract
Biosimilar drugs, structurally identical and manufactured similarly to original biologic drugs, offer potential cost reductions in therapeutic practice, albeit with variations in adoption across European countries. This review synthesizes findings from literature examining legislative decisions and their effects on biosimilar market entry in Europe. Drawing from scientific articles and official documents, the review reveals that biologics constitute 36% of European drug expenditure, with the market valued at €78.6 billion in 2021 and growing annually at 10.5% over the past five years. Approximately 15% of new active substances centrally approved by the EMA in 2020 were biologics. The European biosimilars market is projected to reach €8.8 billion in 2021. Various measures are being implemented to boost biosimilar uptake, including pricing strategies, reimbursement policies, and substitution practices. Access, measured in terms of availability and time to entry, is still difficult in a number of countries, but legislative measures are helping biosimilars enter European markets more quickly.
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