OBJECTIVES

: Recent years have witnessed EU markets updating their biosimilar policies; however, there remain countries where the full cost-savings potential of biosimilars is yet to be realized. This research aims to review the current EU biosimilar landscape, and to investigate the most recent policy shifts as an indicator of expected evolution in the post-COVID environment, as payers express growing interest in healthcare savings.

METHODS

: A qualitative assessment of current EU biosimilar policies was performed, followed by an investigation into emerging global policy shifts, to provide insight into the future direction in which the biosimilar landscape in the EU is shifting. Findings were used to identify trends and predict the changes we should expect in the post-COVID context.

RESULTS

: The most sophisticated regulatory and pricing environments for biosimilars were identified in Germany and the UK, with policies including regional quotas and reference price groups, respectively. Conversely, markets where streamlined biosimilar access pathways remain lacking include Italy, Spain, Austria, Poland, Romania and Turkey, together with the markets in which there are no legislative measures or recommendations to support uptake at the prescriber-level, such as Bulgaria, Czech Republic, Estonia, Ireland and Slovakia. Investigation of the most recent policy updates highlighted a focus on eradicating barriers to market access. In Italy, a streamlined procedure for pricing and reimbursement of biosimilars was introduced in October 2020. The UK has followed suit and introduced a new licensing pathway specifically for biosimilars, which will not require comparative efficacy data. Beyond EU, Quebec represents one of the example markets that recently announced intention to enforce biosimilar switching, becoming the fourth Canadian province to do so.

CONCLUSIONS

: Emerging policies indicate that future shifts will tackle biosimilar uptake from multiple fronts, with market access policy updates likely to include introduction of abbreviated reimbursement pathways for biosimilars, while switching policies drive uptake at the prescriber-level.