A Look at the History of Biosimilar Adoption: Characteristics of Early and Late Adopters of Infliximab and Etanercept Biosimilars in Subregions of England, Scotland and Wales - A Mixed Methods Study

Abstract

Background Regions within England, Scotland and Wales show variation in rate of adoption of biosimilar infliximab and etanercept. Objectives This study aims to examine how local decisions and practices in regions within England, Scotland and Wales might explain initial variation in market dynamics of biosimilar and originator infliximab and etanercept. Methods Market data provided by the National Health Service (NHS) on biosimilar and originator infliximab and etanercept uptake were analysed for the 10 historical regions of England, 14 health boards in Scotland and 7 health boards in Wales (2015)(2016)(2017)(2018). Findings were discussed in ten semi-structured interviews: on a national level with an industry representative (1), on a regional level with NHS employees in England (6), Scotland (1) and Wales (1), and on a local level with a representative of a clinical commissioning group in England (1). Results Tenders for infliximab and etanercept in England, Scotland and Wales have consistently resulted in a biosimilar as the best value biological. Early and late biosimilar adopters are seen, with overall convergence towards high biosimilar market shares over time. Qualitative results suggest that biosimilar adoption was positively influenced by (a) a price difference between biosimilar and originator product making it worthwhile to switch patients; (b) a good relationship between commissioner and provider in England resulting in gain share agreements; (c) leadership on biosimilars in regional NHS offices in England or Scottish and Welsh health boards; (d) key opinion leaders or leading hospitals that start using biosimilars early and gain experience. Conclusions This study has shown that the savings potential drives biosimilar use. Regions with a proactive attitude, good stakeholder relationships, and clinician engagement were identified as early adopters.Steven Simoens and Isabelle Huys: Joint last authors.

Community pharmacists' preparedness for substituting biologics and dispensing biosimilars – Lessons learned from a multinational survey

“… 11 However, market uptake of biosimilars varies across countries and regions, and acceptance among stakeholders is a topic of debate. 12 , 13 …”

Evaluating the benefits of TNF-alfa inhibitor biosimilar competition on off-patent and on-patent drug markets: A Southern European analysis

“…The study methodology was designed according to published research analyzing markets for TNF-alfa inhibitors prior to and following biosimilars availability (Moorkens et al, 2019a;Moorkens et al, 2019b;Moorkens et al, 2020;Moorkens et al, 2021). We first conducted a literature review to describe aspects specific to the immunomodulators and TNF-alfa inhibitors market in Italy, Portugal and Spain.…”

“…Previous studies conducted by our research group have focused on capturing the effect of TNF-alfa inhibitor biosimilar competition within the TNF-alfa inhibitors class (Moorkens et al, 2019a;Moorkens et al, 2019b;Moorkens et al, 2020;Moorkens et al, 2021). However, biosimilars availability may also influence market dynamics for competing products in other therapeutic classes.…”

“…This figure is likely to increase in the coming years, as biosimilar market shares expand and the economic impact of exclusivity losses for biologics rises (IQVIA, 2021a). However, the level of competition generated by biosimilars varies according to the country's biologics market, the care setting, and the molecule (Rémuzat et al, 2017;Moorkens et al, 2019a;Moorkens et al, 2019b;Moorkens et al, 2020;Moorkens et al, 2021). In this context, biosimilars contribution to attaining price reductions and extended access to treatments also varies (IQVIA, 2020b).…”

An exploration of biosimilar TNF-alpha inhibitors uptake determinants in hospital environments in Italy, Portugal, and Spain

“…The coordination of policies for biosimilars market entry, pricing, purchasing, reimbursement, and uptake at the individual Member States level, explains observed country-specific biosimilar adoption patterns. Further, it is known that the adoption of biosimilars in a country varies with the care setting, the therapeutic area and the drug class (4)(5)(6). Diverse European experiences have shown the advantages of complementing biosimilar policies targeting biologic-naïve patients with policies aimed at biologic-experienced populations (e.g., switching policies).…”