Biosimilars: What Can the United States Learn From Europe?

Sonia T. Oskouei, PharmD, is the Director of Pharmacy Program Development for Biosimilars at Premier Inc. Within the provider-led organization, she has the unique role of leading the national biosimilar strategy on behalf of nearly 3800 hospitals and health systems. Through the development of educational resources and tools, she supports health system stakeholders evaluate and manage biosimilars, and works with biosimilar manufacturers on market considerations including financial, clinical, and operational decisions. She previously oversaw pharmacy purchasing and procurement for Novant Health. 
October 11, 2017
It is no secret that progress in biosimilar product approval has been slow within the US healthcare market. The first biosimilar approved in the United States in 2015 was already available in 60 other countries around the world.1 In fact, more than 700 million patient days have been documented from a decade of biosimilar experience within the European Union.2 The European Union, considered the most seasoned user of biosimilars, has approved the highest number of biosimilars worldwide (with more than 30 products currently approved).3

As of October 1, 2017, there are only 7 FDA-approved biosimilars in the United States, and only 3 have made it to market. While 60% of overall global biologic sales occur in the US, 9 out of 10 biosimilar product sales in 2016 were in the European Union.2 With such significant differences in biosimilar markets across oceans, a large window of opportunity becomes available to gain key learnings from international counterparts.

It is important to recognize that the uptake and acceptance of biosimilars within the European Union varies greatly not only by country, but by therapeutic area as well. The amount of government involvement, reimbursement systems, and tender procurement policies all contribute to variations in adoption rates among regions. Of course, the regulatory and payer environment also varies greatly among EU member states and the United States. Despite these differences, it is important to not dismiss the decade-long EU biosimilars experience, including overcoming barriers to enhance product uptake. Trends and lessons can be applied to the domestic market to understand the potential impact of biosimilars on patient care and accessibility.

As providers and patients continue to gain familiarity with biosimilars in the United States, the European Union has been able to make significant progress in raising stakeholder awareness, despite initial concerns with the category of drugs as well. In fact, education remains a priority in the European Union, with regulatory bodies such as the European Commission (EC) and European Medicines Agency (EMA) leading stakeholder education on biosimilar medicines.2 In Denmark, where a national tender system is used, the infliximab biosimilar has become a first-line product for biological treatment in both rheumatology and gastroenterology, resulting in immediate uptake of the biosimilar in clinical practice.2 As part of the conversion, the government consulted with payers, regulators, and physicians to develop patient education resources.2 There are key lessons to learn from the European Union on the significant need for multi-stakeholder, multifaceted biosimilar education within the United States.

Ensuring continuous engagement of providers, payers, and patients has proven to be critical to EU biosimilar acceptance. Additionally, involvement of regulatory agencies in the education process not only signifies the importance of these products, but also serves as a “non-branded” source of education to support overall biosimilar awareness. While the FDA continues to develop guidance on biosimilars, intentional educational efforts with various stakeholders, including providers, payers, and patients will remain crucial. Ultimately, empowerment through education will help healthcare members and patients make informed decisions regarding treatment options.



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