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New pharmaceutical law promotes generics in Chile Posted 24/08/2012

In July 2012, a new pharmaceutical law was introduced in Chile. The new law aims to regulate generics bioequivalence in the country as well as enforce prescription by generic name in order to increase the use of generics.

Chile already offers significantly lower fees for the registration of generics and biosimilars than for the registration of a new product. But with this new law the country aims to achieve bioequivalence of all generics on the market by the end of 2014.

This new public policy on bioequivalence is currently collected in the regulation of the national control of pharmaceutical products for Human Use (D.S. No 3/2010).

The law requires bioequivalent drugs (both generics and originators) to be readily identifiable by having a yellow seal, which must occupy 25% of the surface on at least four of the six faces of the packaging.

From 22 August 2012, the Chilean Public Health Institute (Istituto Salud Publica, [ISP]) may initiate summary proceedings against laboratories that do not include the bioequivalence seal on their boxes and can also impose economic sanctions.

The purpose of the bioequivalence seal is to provide patients with a mark that is easy to see and recognise and represents a guarantee of quality for the buyer. The bioequivalence mark can only be awarded by the ISP once bioequivalence has been proven. The aim is to improve access to medicines in Chile by providing equivalent generic drugs at lower prices.

ISP has certified 70 products to date as bioequivalent. That is, it has been shown that medications containing the same active ingredient (or molecule), made by two different laboratories are therapeutic equivalents. This means that the amount and the speed with which the active ingredient reaches the bloodstream is the same in comparative terms, therefore, it can be expected to produce the same effect in the patient.

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Proposed biosimilars guideline for Chile

Source: IHS, ISP, Nacion.cl

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