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In December 2014, Public Citizen released a report documenting how companies that make biologic medications are using their political clout to price-gouge and maintain indefinite monopolies on their products.[1] As a result of this practice, many patients who could benefit from these medications cannot afford them.
Biologics differ from traditional drugs in that their molecular structures are much larger and more complex, due to the fact that they are large proteins and not chemically...
In December 2014, Public Citizen released a report documenting how companies that make biologic medications are using their political clout to price-gouge and maintain indefinite monopolies on their products.[1] As a result of this practice, many patients who could benefit from these medications cannot afford them.
Biologics differ from traditional drugs in that their molecular structures are much larger and more complex, due to the fact that they are large proteins and not chemically active small molecules. They generally are produced in living systems, such as bacteria or animal or plant cells. In contrast, small-molecule drugs — the drugs most familiar to our readers — are typically made through less complicated chemical synthesis. Biologics, which typically must be given by injection or intravenous infusion, have become especially important in the fields of oncology, rheumatology and endocrinology.
Many of the 125 biologics marketed in the U.S. have staggering price tags, costing $40,000 or more per year of treatment. In contrast to small-molecule drugs, where generic competition has markedly reduced costs, only brand-name versions of biologics currently are available. The competition generated by generic versions of biologics, known as biosimiliars, would no doubt save enormous amounts of money: By one estimate, introduction of biosimilars would save $250 billion in health care costs over the next decade. But due in part to biologic companies’ efforts, biosimilars have yet to be approved by the Food and Drug Administration (FDA).
Public Citizen’s report highlighted multiple actions by biologics companies to create barriers to generic competition. For example, the biologics industry has lobbied at the federal and international levels to demand that biosimilars not share generic names with brand-name products. If the two products have different generic names, doctors and patients likely will doubt whether the biosimilar products can legitimately be substituted for the brand-name version. Likewise, the industry has aggressively campaigned at the state level to impose burdensome requirements on pharmacists who would seek to substitute FDA-approved biosimilars for brand-name products, as they now do routinely with generic drugs.
To speed competition, Public Citizen recommended that the FDA adopt a system for approving biosimilars, ensure that biosimilars designated as interchangeable share the same generic name and make sure that states do not adopt rules that may block pharmacists from dispensing biosimilars. These and other common-sense actions would promote the development of biosimilars and save patients and taxpayers hundreds of billions of dollars in the future.
References
[1] Public Citizen. Competition inhibitors: How biologics makers are leveraging political power to maintain monopolies and keep prices sky-high. December 18, 2014. http://www.citizen.org/documents/report-biologics-industry-leverages-political-power-to-maintain-monopolies-and-inflate-prices.pdf. Accessed January 15, 2015.
