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07/27/2018 Pharmaceutics 0

Specialized Generics

What are generic drugs?

A generic medicine is any one that has the same qualitative and quantitative composition in active ingredients and the same pharmaceutical form as an original medicine.

How is the generic drug different from the brand?

The main difference is in the denomination : the generic medicine acquires the name of the medicinal substance that composes it.

Generics are commercialized in the market once the patent for the original medicine has expired and has been authorized by the Ministry of Health.

What are the advantages of generic drugs?

The main advantage of generic drugs lies in saving the final price of sale to the public, which can be up to 60% less than the price of the original medicine, since the generics do not affect the investments made by each pharmaceutical company in discovering the medicine.

Is the quality of the generics the same as the originals?

Yes, since generic drugs are subject to the same procedures and controls as other medicines and are approved and recognized by the Ministry of Health.

The entity verifies that all medicines that are marketed in Colombia, including generic medicines, comply with international standards of safety, efficacy and quality before granting a sanitary registry.

This includes, for example, the certification of Good Manufacturing Practices (GMP) that guarantees the use of quality raw materials, appropriate facilities for manufacturing and adequate and sufficient tests to demonstrate the quality of the product, explained the Director at the end of the Generic Drugs Forum: Myths and Truths held this Thursday in Bogotá with the Colombian Medical Federation and Fedesalud.

Invima requires that bioequivalence studies be presented on some drugs with special characteristics, such as drugs with a narrow therapeutic margin, to ensure that the same amount of active ingredient is delivered in the same time as the brand product, said the Director of the entity.

Finally, Invima, which has been certified by the Pan American Health Organization (PAHO) as the reference agency of the Americas for medicines, has followed up on the products that are marketed in Colombia and has not found significant differences between the original medicines of brand and generics.