OBJECTIVES: On April 21, 2023, the EMA-HMA published a statement on the scientific rationale supporting the interchangeability of biosimilars, by recognizing their clinical equivalence to originators based on almost two decades of Real-World Evidence. Since the implementation of switching and substitution policies without prescriber’s consent falls outside the EMA’s jurisdiction, this research’s aims to explore payer reactions to this endorsement and potential impacts in biosimilar utilization policies in five key European countries.

METHODS: We reviewed EMA statements on biosimilar interchangeability, alongside country-specific guidance on biosimilar use across France, Italy, Germany, Spain and the U.K.. Primary research with payers will assess perceptions on the joint statement and the downstream impact on biosimilar access.

RESULTS: Policies of five key European countries have been evolving towards a more conducive environment for biosimilars. For example, the U.K.’s MHRA has discontinued the requirement for biosimilars to undergo confirmatory efficacy trials as a licensing condition in 2021, and most key European countries currently allow switching to biosimilars. However, in France, Italy and the U.K. this practice is still physician-driven (no mandatory INN prescribing), and automatic pharmacy substitution is only permitted in France (with restrictions). Alongside market-specific movements to further enable biosimilar adoption, we anticipate this joint statement will give EU payers a significant incentive to implement automatic substitution policies, although some backlash from healthcare providers is still expected.

CONCLUSIONS: Although payers do not feel comfortable enforcing automatic biosimilar substitution as of yet, the recognition of biosimilar interchangeability by the EMA could be sufficient to alleviate any remaining payer and healthcare provider concerns surrounding bioequivalence, drive future policy changes and increase patient access to biosimilars.