Understanding Generic Drugs: An Overview
What are Generic Drugs?
A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use. Though they are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.
Development and Approval Process
To gain approval for a Generic Drugs , pharmaceutical companies must submit an abbreviated new drug application (ANDA) to the regulatory authority demonstrating that they are equivalent to the reference listed drug (RLD) already approved. This involves conducting bioequivalence studies comparing the performance to the RLD. If approved as having the same active ingredients, dosage form, safety, strength, route of administration, quality, performance characteristics and intended use, the generic can be substituted for the RLD without a prescription specifying the RLD.
Cost Savings
Since they don't require repeating expensive clinical trials to prove efficacy and safety, they can be priced significantly lower than their branded counterparts. This allows for substantial savings to patients and the healthcare system. Cost savings from generic drug use in the U.S. has been estimated to be over $1 trillion dollars over the past decade. Several studies indicate that the price of a drug averages between 15-60% of the originator brand price. Cost is often a major factor driving patient and physician choice to switch to generic equivalents once they become available.
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