OBJECTIVES

: To explore the combined impact of competition, interchangeability, procurement, and pricing on the sustainability of the European Biosimilar Medicines market.

METHODS

: A meta-analysis was conducted across a set of studies (n=20) undertaken by GfK since January 2015 involving the pricing and market access of biosimilars, biooriginals, and patent protected biologics in Europe in inflammatory diseases. The studies involved primary research, system dynamics modelling, and war gaming (competitive simulation). Primary research comprised interviews (n=250) across several European markets (n=8), collecting insight at pan-European, National and Regional levels, Physicians, Payers, Patients, and Industry. War gaming and analogues were used to explore the forces of supplier and buyer power, impact of new entrants, impact of substitutes, and competitive rivalry.

RESULTS

: The analysis showed that substitution and switching have occurred more quickly than originally forecast by industry experts and policy influencers, and that this is the primary dynamic in the market. The key drivers of purchasing, access, and profitability in markets where biosimilars compete are relative effective net price, the speed of price erosion (magnitude of discounting), and multi-criteria decision-making. Both sustainability and profitability are driven by differentiation. War gaming indicates that with an increasing number of competitors the biosimilars market will become less sustainable, and that markets that recognize the above drivers and dynamics, and address them with appropriate policies, will deliver sustained benefits to all stakeholders, including the opportunity for cost savings that can be used to fund access to the next generation of innovative new high cost / high value therapies.

CONCLUSIONS

: As the biosimilars market grows to cover more disease areas with more competitors there is a need for increased transparency and tracking of commercial offerings, interchangeability, procurement, and pricing in order to inform appropriate policy that would maintain the sustainability of the European Biosimilar Medicines market.