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• W3121137429 abstract "I. INTRODUCTIONMost drugs are small. Aspirin, for instance, is made up of just 21 atoms. Small drugs like aspirin provide the majority of global revenue for brandname drug companies. But finding new small-molecule drugs keeps getting harder, and generic drug manufacturers are quick to compete with brandname firms once patents expire.1 As a result, drug companies are increasingly turning to very large drugs: biologics produced by living cells.2 In terms of size and rough complexity, if an aspirin were a bicycle, a small biologic would be a Toyota Prius, and a large biologic would be an F-16 fighter jet.3 Biologics provide promising new avenues for doctors to better treat patients, and-not coincidentally-for drug companies to profit. But making biologics is more complex than making small-molecule drugs, and that complexity raises serious challenges for innovation and competition policy in the biopharmaceutical industry.Biologics represent attractive investment opportunities for drug companies. Spending on small-molecule drugs is close to stagnant, especially in developed countries. In contrast, annual global spending on biologics was $93 billion in 2006, rose 69% to $157 billion in 2011, and is expected to rise another 30%, to between $200 billion and $210 billion in 2016.4In the United States, percentage expenditures on biologics will be even more substantial. Indeed, some health care industry analysts predict that in the United States so-called specialty drugs-a category that overlaps substantially with biologics-will represent half of annual prescription drug spending by 2020.5To some extent, the money reflects changes in medicine: Biologics represent many of the most prominent, and promising, new treatments for cancer and other major diseases. They include Avastin, an anti-cancer therapeutic protein with $6.1 billion in global 2012 sales; and the three bestselling therapies of 2012, Humira ($9.3 billion), Remicade ($9.1 billion), and Enbrel ($8.1 billion), each used to treat rheumatoid arthritis.6But total sales revenues also reflect high prices. Although biologics are prescribed less frequently than the most popular small-molecule drugs, they have an average daily cost in the United States that is 22 times higher than small-molecule drug therapies.7Differences in intellectual property protection drive much of the price differential between small molecules and biologics. In general, under the Hatch-Waxman Act of 1984, the originator firms' small molecules are protected by patents and by a short (five-year) period of exclusivity over the clinical trial data the originator must generate to secure approval by the Food and Drug Administration (FDA). After that short exclusivity period, Hatch- Waxman treats the originator clinical trial data as informational infrastructure whose social value is maximized through some level of competitor access.8 Specifically, competitors can bypass conducting their own duplicative clinical trials on the same molecule and secure FDA approval based on the originator firm's data. The five-year regulatory exclusivity, which begins once originator marketing has begun, typically expires well before originator patents expire. Thus, once small-molecule patents expire, the usual result is pricing at or near marginal cost. Generics now represent more than 80% of all small-molecule prescriptions in the United States.In contrast, until 2010-more than three decades into the biotechnology revolution and well after many relevant patents had begun to expire-the United States had no mechanism by which competitors could rely on originator data for biologics. And only as of July 2014, four years after the establishment of a pathway in the 2010 Biologics Price Competition and Innovation Act (BPCIA),9 did the FDA finally accept its first application for a biologic.10 In contrast, the European Medicines Agency (EMA) started approving follow-on biologics in 2006 and has now approved 21 follow-on, or biosimilar, products. …" @default.
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• W3121137429 date "2016-03-01" @default.
• W3121137429 modified "2023-09-27" @default.
• W3121137429 title "Manufacturing Barriers to Biologics Competition and Innovation" @default.
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