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Generics – bioequivalent versions of branded drugs

Date Added: March 03, 2010 12:51:58 AM
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Category: Education Training And Employment
 
According to the U.S. Food and Drug administration (FDA), to receive FDA approval, a generic medicine must: comprise bioequivalent active ingredients as the innovator medicine (inactive ingredients may differ), be identical in strength, dose form and route of administration; meet the same batch requirements for identity, potency, purity and quality; be produced under the same fixed standards of FDA's Good Manufacturing Practice regulations obligatory for branded drugs. To put it differently, their pharmacological effects are identical to those of their branded versions. Although generic drugs are chemically bioequivalent to their brand name counterparts, they are commonly sold at considerable discounts from the trade name price. Generic medicines are estimated to save customers $8 - &10 billion per year at retail pharmacies. Even much more money is saved when hospitals use generic drugs. The key reason for the comparatively low cost of generic medications is that competition escalates among manufacturers when medications no longer are protected by patents. Producers spend less money on creating a generic drug, and are, hence, able to sustain profitability at a lower price to consumers. The costs of these generics are so low that many developing countries can easily afford them. For instance, Thailand is going to purchase millions of doses of the generic version of Plavix, a blood-thinning medicine to prevent heart attacks, at a price of 3 US cents per dose from India, the leading manufacturer of generic drugs. Makers of generics do not incur the cost of drug discovery, and instead are able to reverse engineer known medicine compounds to allow them to produce identical versions. Firms do not have to prove the safety and effectiveness of the medications through clinical studies, for these trials have already been carried out by the trade name company. Sometimes, generic versions of a medication have different colors, flavors, or combinations of inactive ingredients in comparison to original medications. According to the U.S. Trademark law, generic medications are not allowed to look exactly like branded medications. Still, active ingredients in both preparations must be identical, ensuring that both have the same medicinal properties.
 
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