Arnold Ventures suggests ways the FDA and other governmental entities can get more biosimilars into circulation, faster.
Despite legislation designed to facilitate biosimilar competition, “structural challenges” have hindered adoption of these money-saving drugs, and several policy initiatives could spur faster and wider biosimilar use in the United States, according to the philanthropic advocacy group Arnold Ventures.
In a health policy brief, Arnold Ventures suggested multiple policy changes the FDA, lawmakers, and CMS can implement to expand access to biosimilars and promote more savings. These include changing the biosimilar naming convention, easing requirements for biosimilar approval, stimulating biosimilar use with higher reimbursement policies, and proactively investigating anticompetitive practices, the group said.
Early estimates of achievable biosimilar savings from 2017 to 2026 ranged as high as $150 billion, according to the report.
“Actual uptake has lagged behind these savings estimates. By the end of 2018, seven biosimilars had launched in the US market, but sales for these products [represented] less than 1% of all US biologic sales volume,” the report said. There are 28 approved biosimilars and 18 launched biosimilars in the United States. By comparison, over 60 biosimilars have been authorized in Europe, and according to Arnold Ventures, these are marketed at discounts up to 70%.
In the United States, barriers such as excessive product patenting, deliberate misinformation surrounding biosimilar equivalence, and restrictive payer formularies combine to prevent biosimilars from achieving the success that generics have seen. In the United States, generics accounted for 90% of prescriptions and saved nearly $300 billion in 2018, according to Arnold Ventures. Specialty drugs, which include biologics and biosimilars, currently account for 43% of medicine spending, according to IQVIA.
Actions for Congress
In particular, the brief calls on congressional leaders to work with the FDA to discuss whether factors distinctive for biosimilars, such as random-letter name suffixes and interchangeability designations, are even necessary, given that they are not required for other types of drug products. The authors argue that these requirements can create confusion among patients and providers about biosimilars.
Some studies have shown that 4-letter suffixes to distinguish biologics from one another can cause patients to perceive biosimilars as less similar to original brand drugs and affect their willingness to use them.
Interchangeability designations, which allow for greater access to biosimilars by allowing them to be switched with originators at the pharmacy counter, may require biosimilar manufacturers to perform costly and lengthy switching studies.
On a state level, policymakers need to guarantee that substitution laws give pharmacists flexibility to exchange expensive biologics for cheaper biosimilars without needing to seek permission from a physician, the Arnold Ventures report said.
The brief also said that Congress could direct the Federal Trade Commission to investigate anticompetitive practices used by originator manufacturers, including pay-for-delay deals, rebate traps that discourage biosimilar uptake, and misleading advertising about biosimilars.
The group also recommended that Congress increase reimbursement for biosimilars under Medicare Part B or require that biosimilars be used before costlier formulations. A version of this concept has been proposed in the Senate (S 2543) and would provide a temporary reimbursement increase of 2% over 5 years for biosimilars.
FDA and CMS Changes
The group said the FDA should evaluate whether biosimilars are being be held to higher standards than originator products, such as requirements for additional switching studies to demonstrate biosimilar interchangeability with reference products.