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Biosimilar drugs could cut U.S. health spending by $54 billion

Staff Writer |
Introducing "biosimilar" versions of complex biologic drugs could cut health care spending in the United States by $54 billion over the next decade.

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This is according to new analysis from the RAND Corporation.

The savings estimate is about 20 percent larger than a similar analysis done by RAND researchers three years ago, representing both improved analysis methods and rapid growth in spending for biologics overall.

"Biologics account for the fastest-growing segment of prescription drug spending, but biosimilars have the potential to help slow some of the increase," said Andrew Mulcahy, lead author of the study and a policy researcher at RAND, a nonprofit research organization.

Biologics are complex, protein-based drugs manufactured in living systems
"However, there remains many important industry, regulatory and policy decisions to be made that will influence whether such savings are realized."

Biologics are complex, protein-based drugs manufactured in living systems and include insulin, monoclonal antibodies to block inflammation in rheumatoid arthritis, and a range of drugs to treat cancer, multiple sclerosis and other serious diseases.

Biologics accounted for 70 percent of the growth in prescription drug spending
While biologics are important treatments for many conditions, they often are expensive and patient copays for the treatments can be several thousand dollars per year.

While 1 percent to 2 percent of the nation's population is treated with a biologic each year, the drugs accounted for 38 percent of prescription drug spending in 2015.

In addition, biologics accounted for 70 percent of the growth in prescription drug spending in the U.S. between 2010 and 2015.

Biosimilars are very similar to already approved "reference" biologics in terms of potency, safety and efficacy, but manufactured by different companies.

Biosimilars can be approved for marketing by the federal Food and Drug Administration after the manufacturer of the reference biologic enjoys several years of patent and exclusivity protection.

The Biologics Price Competition and Innovation Act, enacted as part of the 2010 Patient Protection and Affordable Care Act, authorized the FDA to create a new approval pathway for biosimilars with the goal of promoting competition.

This new pathway is faster and less costly for biosimilar developers.

RAND researchers developed their estimate of savings from biosimilars by examining other studies that have examined the issue, reviewing the sales history of more than 100 biologic drugs and examining the brief experience of the one biosimilar drug that has been marketed in the U.S.

RAND researchers estimate that that biosimilars will cut spending on biologics by about 3 percent over the next decade.

The range of the new savings estimate given reasonable ranges of key assumptions - like the price of biosimilars versus reference biologics and biosimilar market share - varied from $24 billion to $150 billion from 2018 through 2027.

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