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Anthony Vecchione is Executive Editor of Drug Topics.
By 2008, worldwide sales of generic drugs will grow by more than 20% a year and reach $80 billion, according to IMS Health. Currently, the world generic market is worth about $35 billion. At a recent meeting of the International Generic Pharmaceutical Alliance, IMS officials predicted that low-cost copies of drugs that have lost patent protection would overshadow the brand pharmaceutical sector. IMS anticipates that sales of generics will grow by an annual rate of 22.1% over the next five years in leading world markets, including the United States, Italy, Canada, Germany, France, Spain, and Britain.
Sluggish sales of its urology and contraceptive products and a slower than expected push into the brand-name pharmaceutical business has prompted generic drug giant Watson Pharmaceuticals to cut dozens of jobs nationwide. The cutbacks are part of a major reorganization plan announced recently by the Corona, Calif.-based company. The job cuts are expected to impact employees at Watson facilities in Morristown, N.J., Salt Lake City, and at the firm's headquarters in California. Watson employs 3,800 people worldwide.
Calling it a significant move toward saving American consumers billions of dollars on drug products, the Generic Pharmaceutical Association (GPhA) applauded a recent Senate Judiciary Committee hearing on generic biopharmaceuticals. The hearing elicited testimony from experts in the generic and biopharmaceutical industries on the establishment of an efficient and effective regulatory pathway that will enable FDA approval of more affordable generic versions of expensive biopharmaceutical products. Representatives from GPhA and the generic industry outlined the science as it now exists for approving affordable biopharmaceuticals, urging Congress to open the regulatory pathway to foster competition in this $30 billion a year marketplace.
U.S. patents have expired or will expire within the next few years on more than a dozen biopharmaceuticals. GPhA officials noted that the introduction of generic versions of these products would translate into a significant cost-savings for consumers. GPhA experts informed the panel that advances in science over the past 20 years support the development of safe and effective generic biopharmaceuticals.
The Health Services Purchasing Coalition recently launched a public education campaign outlining the benefits of generic medications. The key messages of the campaign include: Generic drugs are just as safe as their brand-name counterparts; generic drugs are just as effective as their brand-name counterparts; generic drugs undergo the same rigorous review as brand-name medications and must also be approved by the FDA; generic drugs often cost up to 75% less than their brand-name counterparts.
According to the FDA, many consumers are unaware that generic drug manufacturers produce medications that are just as safe and effective as their brand-name counterparts and offer cost savings up to 75%.
Without admitting guilt, GlaxoSmithKline will pay $92 million to settle a class-action lawsuit filed by consumers, health plans, and pharmaceutical wholesalers in 2002 in U.S. District Court in Alexandria, Va. The lawsuit alleged that Glaxo attempted to monopolize the market for its antibiotic drug Augmentin (amoxicillin clavulanate) by preventing the entry of generic manufacturers.
According to a study by researchers at Stanford University and in Zimbawe and Spain, generic antiretroviral AIDS drugs are a viable therapy for patients who have already taken short courses of other agents. Generic antiretrovirals are less expensive than their brand-name alternatives and could make it easier for larger numbers of patients to receive the medications, especially in developing countries. The study team, led by David Karzentein, started 29 patients on a generic form of HAART (highly active antiretroviral therapy) after patients had taken either a single dose of nevirapine or a short course of AZT. After 16 weeks, the researchers discovered that pre- exposure to the other single therapies did not seem to influence the positive response to HAART. These data were presented at the 15th International AIDS Conference in Bangkok in July.