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Generics – bioequivalent versions of brand name drugs |
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| Date Added: March 04, 2010 06:08:52 PM | |
| Author: | |
| Category: Shopping: Health | |
According FDA (U.S. Food and Drug administration, to get FDA approval, a generic medication must: comprise bioequivalent active ingredients as the trade name medication (inactive ingredients may vary), be bioequivalent in effectiveness, dosage form and route of administration; meet the same batch requirements for identity, strength, quality and purity; be produced under the same strict standards of FDA's Good Manufacturing Practice regulations mandatory for innovator medicines. To put it differently, their pharmacological effects are identical to those of their branded versions. Although generic medications are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the trade name price. Generics are estimated to save consumers $8 to $10 billion per year at retail pharmacies. Even much more cash is saved when hospitals use generic medicines. The main reason for the relatively low cost of generics is that competition goes up among manufacturers when medicines no longer are protected by patents. Companies incur fewer costs in creating a generic medication, and are, hence, able to sustain profitability at a lower cost to consumers. The low costs allow many developing countries to easily afford them. For example, Thailand is going to purchase millions of doses of the generic version of Plavix, a blood-thinning medication to preclude heart attacks, at a cost of 3 US cents per dose from India, the leading maker of generic drugs. Makers of generic drugs do not incur the price of medication discovery, and instead are able to reverse engineer known medication compositions to allow them to produce identical versions. Producers do not bear the burden of proving the safety and potency of the drugs through clinical tests, for these studies have already been carried out by the branded firm. Generic medications may at times be shaped differently than trade name versions, such as a generic pill versus a brand name bolus. Still, they have the same active ingredients and are produced under the same standards as branded medicines. |
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