OBJECTIVES:

Biosimilar marketplace growth is rapidly accelerating in Europe, where it has potential to improve sustainability of healthcare systems through significant cost savings. Unfortunately, current policies and practices for biosimilar procurement are inconsistent and poorly defined, with lack of awareness of the system vulnerability. A modified Delphi process was conducted to establish expert consensus on biosimilar marketplace sustainability in Europe and provide a comprehensive strategy for overcoming key challenges and barriers.

METHODS:

A multistakeholder Delphi panel comprising 11 participants (1 patient advocate, 1 oncologist, 1 rheumatologist, 2 hospital pharmacists, 2 procurement pharmacists, 1 national payer, 2 policy advisers, 1 manufacturer) from 7 European countries was conducted in November 2019. All stakeholders participated in a 3-stage process: i) brainstorming supported by a systematic literature review (SLR) and key materials identified by participants; ii) structured feedback on statements derived from brainstorming, and iii) a facilitated roundtable discussion on anonymized feedback. Consensus statements were derived.

RESULTS:

Participants agreed that a sustainable biosimilar marketplace must deliver measurable and transparent benefits to healthcare systems and meet the needs of stakeholders. Key drivers of sustainability were identified: i) competition is more effective than regulation; ii) use of incentives to promote pharmaceutical investment in biosimilar development and biologics innovation; iii) procurement processes must avoid monopolies and minimize market disruption, and iv) principles for procurement should be defined by stakeholders and adhered to. SLR findings were limited, with significant gaps in the impact of different tender models on supply risks, savings, and sustainability.

CONCLUSIONS:

A sustainable biosimilar marketplace means that stakeholders benefit from appropriate and reliable access to treatment, which may be enhanced through collaboration in designing policies, practices, and procurement with continued room for pharmaceutical investment.

Competition amongst approved products will promote a sustainable biosimilars marketplace and could help maintain price, without compromising quality, while delivering savings that may be reinvested.