Regulation of similar biotherapeutic products in Latin America

Regulation of similar biotherapeutic products (SBP) in Latin America varies widely among different countries and, although many countries have yet to introduce guidance for biosimilars, the region is moving towards increasing standards of regulation for these products.

Some intended copies of originator biologicals have already been licensed in Latin America without biosimilars regulations being in place and therefore without adequate clinical testing being performed. In Colombia, an etanercept SBP (Etanar) has been licensed; while in Bolivia, Chile, Peru (Reditux) and Mexico (Kikuzubam) – a rituximab SBP has been licensed, all prior to appropriate regulations being approved.

The rising growth of the middle class in the region has brought about a substantial increase in healthcare spending leading inevitably to increased use of cheaper biosimilars. For example, in Brazil, biologicals account for less than 3% of prescriptions but more than 40% of the government’s drug budget.

Other countries in Latin America already have or are in the process of creating regulations covering SBP, see Table 1.

Table 1: Similar biotherapeutic products regulations in Latin America

The trend in Latin America is to adopt guidelines for biosimilars based on accepted international standards, such as those of the World Health Organization. This is the case in Argentina, Brazil, Chile, Costa Rica, Guatemala, Panama and Peru where recent guidelines have been developed based on and/or taking into consideration internationally accepted standards.

Although many of the guidelines are based on regulations and guidelines from around the world, including the World Health Organization’s ‘Similar Biological Product Guidelines’, one criticism is that they are too vague, for example, the type of studies required, extrapolation to other indications or even which guidelines to be used are left to the regulatory authority. This could lead to different standards for different products and reduce confidence in the use of SBP approved in the region.

Editor’s comment
It should be noted that biosimilars approved outside of the EU might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Related articles

Peruvian guidelines for ‘biosimilar biologic’ products

Argentinian guidelines for similar biological medicines

Colombia issues draft decree for registration of biosimilars

Brazilian guidelines for follow-on biological products

Mexican guidelines for biocomparables

Proposed biosimilars guidelines for Chile

Source: www.gabionline.net

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