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Generics – bioequivalent versions of brand name drugs |
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| Date Added: March 04, 2010 06:33:14 PM | |
| Author: anvgelica19 | |
| Category: Arts: Costumes: By Type: Historic and Folk | |
As the U.S. Food and Drug administration (FDA) has put it, to gain FDA approval, a generic medicine must: comprise bioequivalent active ingredients as the original medicine (inactive ingredients may differ), be identical in strength, dose form and route of administration; comply with the same batch requirements for identity, concentration, quality and purity; be produced under the same fixed standards of FDA's Good Manufacturing Practice regulations mandatory for original medications. To put it differently, their pharmacological effects are identical to those of their branded versions. Though generic medicines are chemically identical to their brand name versions, they are commonly sold at substantial discounts from the trade name cost. According to the Congressional Budget Office, generic medicines save consumers an estimated $8 to $10 billion per year at retail pharmacies. Even much more money is saved when hospitals use generic drugs. The main reason for the relatively low cost of generic medicines is that competition increases among makers when medications no longer are protected by patents. Producers spend less money on creating a generic drug, and are, thus, able to sustain profitability at a lower cost to consumers. The costs of these generics are so low that many developing countries can easily afford them. For instance, Thailand is going to buy millions of doses of the generic version of Plavix, a blood-thinning medication to prevent heart attacks, at a price of 3 US cents per dose from India, the leading producer of generic medicines. Producers of generic medications do not incur the price of medicine discovery, and instead are able to reverse engineer known medicine compositions to allow them to produce identical versions. Companies do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, for these tests have already been conducted by the branded company. Generics may at times be molded differently than brand name versions, such as a generic tablet versus a trade name bolus. Still, they have the same active ingredients and are manufactured under the same standards as branded medicines. |
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