Links Bioequivalence

¿Original or Copy drug?

In Argentina, the approval of law N°25.649 ( August 28th, 2002) that establishes that all medical prescriptions must express the generic name of the medicine, has opened great discussions between regulatory authorities, health care professionals, the pharmaceutical industry and the public opinion. In order to clarify the concepts and to understand the importance of the bioequivalence studies in this matter, we define some concepts:

An original or innovator drug: is the one that contains a new active ingredient on which a complete research and development has been made. It is therefore the first, and sometimes the only one, that contributes to own data of security and therapeutic effectiveness. The developing, proprietary laboratory of the rights, commercializes it under a registered brand-name. Once the patent rights expired, the active ingredients contained in innovator products can be commercialized freely by different laboratories.

A copy or similar drug: In our country, the drugs that can be grouped in this category are those that appear in the market after the innovator drug, containing the same active ingredient, but without the license of the brand-name product. They fulfill the same quality criteria as the innovator drugs and they base their security and therapeutic efficacy data on published documentation that exist on the active ingredient.

In Argentina, the copy or similar drugs are not generic drugs.

A generic drug: is a medicine with the same pharmaceutical form and equal qualitative and quantitative composition than the innovator product. It must demonstrate therapeutic equivalence by means of bioequivalence studies (ANMAT 3185-99, 3311-01). The generic drug is interchangeable with the reference product since they have the same therapeutic effectiveness. They can only be commercialized once the patent of the innovator brand-name product has expired.

Source: Ministerio de Salud y Ambiente de La Nación

ANMAT regulations