An examination of national policies on biosimilars in 10 European Union member states concludes that supply-side policies targeting price can limit biosimilar penetration in the long term, while demand-side policies positively impact biosimilar uptake and are important drivers for biosimilar market penetration.
An examination of national policies on biosimilars in 10 European Union (EU) member states concludes that supply-side policies targeting price can limit biosimilar penetration in the long term, even though such policies create short-term savings. However, demand-side policies positively impact biosimilar uptake and are important drivers for biosimilar market penetration.
Demand-side policies include:
The study, published online in the Journal of Market Access & Health Policy, comprised a comprehensive literature review that identified supply-side and demand-side policies and their effect on biosimilar uptake in the 10 member states that have the highest pharmaceutical expenditures in the EU: Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the United Kingdom.
Supply-side policies are measures that are primarily directed at specific healthcare-system stakeholders who are responsible for the pricing and reimbursement of medicines. These policies include price regulation, health technology assessments (HTA; systematic, multidisciplinary evaluations of properties, effects, and/or impacts of health technology to evaluate the social, economic, organizational, and ethical issues of a health intervention or health technology), and procurement conditions. Supply-side policies affecting biosimilars commonly include price linkage, price reevaluation, and tendering. The use of internal or external reference pricing varies between countries.
Demand-side policies are measures that are directed toward stakeholders who prescribe, dispense, and ask for medicines. Demand-side policies use pharmaceutical prescription budgets or quotas along with the monitoring of prescriptions (with potential financial incentives or penalties).
The researchers said that, despite significant differences between biosimilar and generic markets, they saw similar trends with respect to the factors potentially influencing generic and biosimilar uptake. “Biosimilars should be distinguished from generics in terms of higher development costs due to their complexity and development requirements,” they state.
The authors found that supply-side regulations targeting price in general limit the penetration of biosimilars in the long term even as they create short-term savings. In contrast, demand-side policies have a positive impact on uptake: “Supply-side policies aim to push biologic reference medicine and biosimilar prices down to generate savings, but significant compulsory price cuts on biosimilars are considered disincentivizing for manufacturers,” the researchers explain. “To compete with biosimilars, reference medicine manufacturers would be tempted to cut their prices to maintain the uptake of branded biologics, thus reducing competition and decreasing the revenue profitability of biosimilar producers.” Decreasing competition following biosimilar entry would ultimately lead to price increases in the longer term.
The authors note that switching biosimilars for reference biologics is generally allowed in the EU, though switching is solely the physicians’ responsibility, as automatic substitution is forbidden in most EU member states. Thus, prescribers’ positive attitudes toward, and trust in, biosimilar medicines should be a priority.
However, the researchers point out, studies have shown that physicians’ familiarity with biosimilars is not yet satisfactory, and that prescribers perceive the information on biosimilars to be both insufficient and untrustworthy. The authors recommend implementing HTAs to create opportunities to satisfy both patients’ and physicians’ needs for better education about biosimilars and to potentially increase biosimilar acceptance. Germany, for example, has a high biosimilar uptake rate and has implemented several demand-side policies such as prescription budgets, quotas, financial incentives, and informational campaigns.
“Understanding that a return on investment is needed to ensure the sustainability of the biosimilar industry is critical for achieving both the economic savings associated with biosimilar entries and the health benefits associated with a wider use of biologics,” the authors conclude. “Further research is needed to inform biosimilar supply- and demand-side policies within the EU.”
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.
Review Highlights Most Popular European Policies to Boost Biosimilar Uptake
April 3rd 2024Although tender systems are a common strategy to encourage biosimilar utilization across Europe, policies like automatic substitution are rarely utilized, according to a systematic review of European policies and biosimilar uptake.