For years, we have seen healthcare professionals struggle to educate entire societies about the use of generic drugs. Breaking the myth that a generic is of lower quality than a brand name drug has been a challenge.
According to the parameters of the US Food and Drug Administration FDA for its acronym in English, a generic is a drug created to be the same as a brand name drug in terms of dosage, safety, potency, route of administration, quality and performance characteristics.
These similarities help demonstrate bioequivalence, which means that a generic drug works the same way and provides the same benefit as its brand-name version.
Any generic drug created with a brand-name drug as a model has the same effects on the body.
“A generic is the same as a brand name drug in terms of dosage, safety, effectiveness, potency, stability, and quality. They use the same active ingredients and work in the same way, so they have the same benefits”, says Rodrigo López, professor of Chemistry at UMECIT University.
The FDA implements rigorous controls to ensure that generic drugs meet these standards, in addition to inspecting 3,500 manufacturing plants a year and monitoring the safety of drugs after they have been approved and released to the market.
An FDA research study compared generic drugs with brand name drugs and found that there were minimal differences of approximately 3.5% in absorption in the body. This difference is completely acceptable.
Generic and brand-name drugs share the same active ingredient, but other characteristics, such as color and taste, that do not affect the performance, safety, or effectiveness of the generic drug, may be different.
This is because new drugs are generally protected by patents that prohibit others from making and selling copies. A patent protects the company’s investment in the development of the drug, by granting the company the exclusive right to sell it while the patent is in force.
Due to the length of time it takes to bring a new drug to market, this 20-year exclusivity period allows pharmaceutical companies to recoup the costs associated with bringing a new drug to market.
“Once these patents and marketing exclusivities expire, the generic drug can be approved,” said the teacher.
Generic drugs also tend to cost less than their brand-name counterparts, since generic drug manufacturers do not have to repeat the animal studies and human clinical studies that were required of brand-name drugs to demonstrate their safety and efficacy.
Multiple company applications are often approved to market a single product; This creates competition in the market that generally results in lower prices.
Lowering the initial research cost means that although generic drugs have the same therapeutic effect as their brand-name equivalents, they are generally sold at substantial discounts, around 80% to 85% less compared to the price of the brand-name drug.
It is important to note that 80% of the drugs that are marketed in first world countries are generic. In Panama, 70% of the sale of drugs in private pharmacies is brand name, despite the fact that our country signed an agreement with the United Nations to promote generic drugs.
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