The use of biosimilars in the European Union and the United States may yield huge savings to healthcare systems over the next five years
The use of biosimilars in the European Union and the United States may yield total savings of $56 billion to $110 billion over the next five years, according to a new report.
The massive healthcare-savings projection results from the fact that, by 2020, eight major biologic medications are expected to lose exclusivity protection, including treatments for autoimmune disorders and diabetes, according to the IMS Institute for Healthcare Informatics’ report “Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets.”
“By opening markets to biosimilar competition, healthcare systems could realize a 30% reduction in price per treatment day compared to originator biologics,” IMS Institute said in a statement. “The extent of actual savings will depend on policy decisions made and actions taken around incentives, education, and pricing.”
The combined value of the eight top-selling biologic medicines losing exclusivity protection between 2015 and 2020 in five countries in the E.U. (France, Germany, Italy, Spain, and the United Kingdom) and the United States is $47.4 billion.
One of the top-selling medications losing exclusivity is Humira (adalimumab), which is indicated for the treatment of multiple inflammatory conditions, including rheumatoid arthritis (RA), Crohns’ disease, and psoriasis. Lantus (insulin glargine) for type I and type II diabetes, which had sales of around $9.7 billion in the E.U. and the United States from January to September 2015, lost exclusivity in the E.U. in 2015.
Another major branded drug losing exclusivity is Enbrel (etanercept), which is used to treat RA, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. While Enbrel’s loss of exclusivity is expected to take place in the E.U. in 2016, it probably will not occur in the United States until 2028.
Approximately 30 companies are actively developing biosimilar medications for launch and are pursuing biosimilar versions of 16 distinct molecules, which will lead to greater competition by 2020.
“This robust pipeline represents an opportunity for payers to realize savings and for physicians and patients to ensure greater access to these important treatments,” IMS said.
Most of the biosimilars in development are for versions of Remicade (infliximab), Enbrel (etanercept), Mabthera (rituximab), and Humira (adalimumab).
Amgen first filed for FDA approval of the biosimilar version of Humira in November, 2015, as well as with the E.U. authorities in late 2015. At least six other biosimilar versions of Humira are in late-stage development, according to IMS Institute.
Further biosimilar versions of RoActemra (tocilizumab), Simponi (golimumab), and Orencia (abatacept) are also in development.
Despite the significant increase in development of biosimilars, the considerable variations across the E.U. in payer policy approaches limit the opportunity for biosimilars in those countries, according to IMS Institute.
“Across Europe, payers have adopted a variety of approaches to encourage physicians to prescribe biosimilar medicines, motivate manufacturers to participate in the market, and provide adequate clinical evidence to support the prescribing of these treatments,” IMS said. However, “not all stakeholders are using competition to maximize in a sustainable way the benefits offered by biosimilars.”
Germany is among the most successful countries in payer policies, educating physicians and implementing measures designed to stimulate biosimilar prescribing.
However, the approach in Austria - where some biosimilar medications are subject to mandatory price reductions that may force manufacturers out of the market - has had the opposite effect, resulting in reduced access to some biosimilars.