IQVIA’s eighth edition of its Impact of Biosimilar Competition in Europe report demonstrated successful uptake in many countries throughout the region. However, not every country has great adoption rates and companies may have a harder time choosing which molecules to invest in for biosimilar development.
In the eighth installment of its “Impact of Biosimilar Competition in Europe” report, IQVIA highlighted the successful uptake of biosimilars across 23 European markets, including rises in biosimilar savings and accessibility, and highlighted areas in need of improvement.
Biologics represented 35% of medicine spending in 2022, and list prices grew at a 11.3% compound annual growth rate over the past 5 years. Although biosimilars account for €9 billion ($10 billion) in annual spending across Europe, the benefits that these drugs provide to patients, payers, and the health care system has far reaching affects, according to the report.
“The past 5 years have been a sign of the maturation of the biosimilars market. The number of new biologic molecules with a biosimilar doubled in the past 5 year period compared to the 10 years prior, and the number of competitors within each market has increased significantly. By 2022 a total of 18 molecules now have direct biosimilar competition and have an average of 3.8 competitors authorised, led by adalimumab which alone has 10 marketed biosimilar medicines authorised in Europe,” wrote the authors.
In 2022, the European Medicines Agency approved 6 biosimilars (a teriparatide, a human insulin, a ranibizumab, an insulin aspart, a bevacizumab, and a pegfilgrastim), bringing the total number of approvals to 74.
Impact of COVID-19 and Biosimilar Savings
The report made several observations about the biologics market, including the global impact of the COVID-19 pandemic and rising inflation, which have led to fragile supply chains and high drug prices.
Countries where patients pay for their biologic treatments out of pocket or with a co-pay, such as Poland, may find it difficult to afford their medications. Additionally, smaller manufacturers of biosimilars have recorded increased costs for packaging and distribution of medications and payers will face increased pressure to create savings and reduce the long-term impact that the pandemic had on health care systems.
Overall, biosimilars provided about 4.5 billion patient treatment days to patients in Europe. In 2022, biosimilars contributed nearly 850 million patient treatment days, up from 750 million in 2021. In 2012, estimates suggested that savings could reach between €12 billon ($13 billion) and €34 billion ($36 billion) in 2020. However, as of 2022, the cumulative savings at list prices reached over €30 billion ($32 billion) thanks to biosimilar competition.
The average uptake rate in the first-year after biosimilars enter the market has increased from between 5% and 40% to nearly 75%, which IQVIA said “reflects and increasing comfort with biosimilar prescribing amongst physicians, and improvements in biosimilar policies.” However, not all areas have experienced great uptake rates, especially insulin markets due the high number of competitors that exists outside of biosimilars. The organization suggests that health care systems should work to create a robust set of policies that support a competitive and sustainable biosimilar market.
Increased Accessibility and Looking to the Future
Although access to biosimilars has increased as a whole, not every country in Europe has easy access to these medications, as there’s been a growing disparity in access in the anti-tumor necrosis factor (TNF), oncology, and insulin markets. In the anti-TNF space, between 1 year prior to biosimilar competition and 6 years after, there has been a 114% increase in access disparity between high-access countries and low-access countries. In the oncology market, there has been a 50% increase in disparity and in the insulin space, a 20% increase.
Over the next 5 years, over 30 molecules will lose patent protection, many of which will be orphan drugs and have biosimilar competitors in the pipeline. IQVIA said that the success of a biosimilar depends on the originator to be present in the market, to be reimbursable, to have gathered clinical experience, and to have a robust collection of data.
The authors noted, “countries that ether cannot afford the originator appear to be missing out or at risk from not benefitting from the biosimilar. The sustainability of the market is a delicate balance of supporting competition, accumulating long-term savings, and preparing for the next wave.”