Study: Biosimilar Uptake in United Kingdom Lower Than Expected

A cross-sectional study published in the International Journal of Clinical Pharmacy in 2017 set out to determine the uptake and acceptance of the first wave of biosimilars marketed in the United Kingdom prior to 2015: somatropin, epoetin, and filgrastim, by local formularies. The results of the study suggest that the uptake of biosimilars in the United Kingdom has been highly variable and generally lower than expected.

Researchers conducted the study from November 2014 to December 2014, using a list of 157 Acute Trusts (accountable organizations within the National Health Service, or NHS, that manage and control performance, service quality, and financial efficiency of hospitals in the United Kingdom) acquired from the NHS England website. The most recent versions of local medicines formularies were utilized and assessed on the following criteria: uptake of biosimilars, compliance to the Medicines and Healthcare Products Regulatory Agency (MHRA) recommendation on brand name prescribing of biologics, and the consideration given to population or indication-specific recommendations.

In total, 146 formularies were identified for inclusion in the study: 129 in England, 10 in Scotland, and 7 in Wales. In terms of joint formularies, which were defined by researchers as a “local formulary that was developed and/or used simultaneously by more than one healthcare providing organization,” 43% of the 146 formularies identified fell into this category.

The formulary uptake and listing approaches differed across the 3 targets groups:

• Somatropin was listed amongst 126 formularies and achieved the highest percentage of medicine listing.
• Epoetin had the highest brand-name listing, with 60 formularies using brand names.
• Although biosimilar versions of filgrastim were the last of the 3 biosimilars considered in this evaluation to receive European Medicines Agency (EMA) authorization, a biosimilar was most commonly listed in preference to the originator.

Variations between the formularies of each country were noted, with 27% of English formularies listing biosimilar filgrastim in preference to the reference product, versus 12.5% and 14.3% amongst Scottish and Welsh formularies, respectively. However, in somatropin and epoetin, 7% and 4% of English formularies preferred the biosimilar over the originator; respectively, though no Scottish or Welsh formularies did so.

Finally, the researchers found that only 6 formularies listed at least 1 biosimilar from all 3 investigated groups. Researchers found no instances of biosimilars being preferred to the reference product across all 3 groups; however, only 2 formularies always listed reference products as preferred to biosimilars.

Overall, the study found that the uptake of biosimilars in the United Kingdom remains inconstant, but generally less than anticipated, especially given that, historically, the United Kingdom’s pharmaceutical market is considerably generic-driven. Researchers note that the principle limitation of the study is using only local medicines formularies as a proxy for actual prescribing practice, which may not necessarily provide an accurate representation of biosimilar prescribing.