MERCOSUR: new tariff for biological and biosimilar without Latin equity

Home/Policies & Legislation | Posted 03/09/2021 post-comment0 Post your comment

Within the pharmaceutical industry, the biosimilars business is growing and consolidating both internationally and locally. It is within this framework that MERCOSUR announced the new tariff to be implemented.

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MERCOSUR is an open and dynamic process. Since its creation, its main objective has been to promote a common space that generates business and investment opportunities through the competitive integration of national economies into the international market. MERCOSUR is the Customs Union between the States Parties to the Southern Common Market. Its full members are Argentina, Brazil, Paraguay, and Uruguay. Venezuela is a full member but has been suspended since 1 December 2016. Associate member countries are Bolivia, Chile, Colombia, Ecuador, Guyana, Peru and Suriname.

On 5 May 2021, by means of the Decree 297, the Argentinian Government incorporated a series of bio-based products to the Common External Tariff (Arancel Externo Común, A.E.C) list. The aim is to establish differential rates of Extra-zone Import Duties (Derechos de Importación Extrazona, DIE).

According to Pharmabiz, the Indian pharmaceutical industry portal, which conducted a special investigation to identify which laboratories are affected, it emerged that there are six active substances of innovator biological products or biosimilars which will be charged with a tariff of 14% as from May 2021, see Table 1. So, it will mainly be the laboratories with Latin equity that have long been inclined to invest in the biosimilars business that will be mostly favoured.

Table 1: Biologicals and biosimilars with 14% tariffª compared to biosimilars produced in Argentina
  Biological/Biosimilar with 14% tariff Biosimilar produced in Argentina
Active substance Product Name Company, Country Product Name Laboratory
bevacizumab Avastin Roche, Switzerland Bevax Elea
Lumiere Elea
Zutrab Richmond
etanercept Enbrel Pfizer, Ireland Enerceptan Amega
Erelzi* Sandoz, Austria
interferon beta 1a Rebif NF Merck, Italy Megavex Blastoferon Amega
Avonex Pen Biogen, Denmark
rituximab MabThera Roche, Switzerland Novex Elea
Rixathon* Sandoz, Slovenia
somatropine Norditropin Flexpro Novo Nordisk, Denmark HHT Pen Biosidus
Hutrope Eli Lilly, France
Zomacton* Ferring, Germany
Saizen Merck, Italy
Omitrope Sandoz/Novartis, Switzerland
Genotropin Pfizer, Belgium/ Germany/Sweden
teriparatide Forteo Eli Lilly, France Osteofortil Biosidus
ªAs from May 2021.

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The brand-new section the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. 

View this week’s headline article: Biosimilares e intercambiabilidad en oncología

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.


Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Vea el artículo principal de esta semana: Biosimilares e intercambiabilidad en oncología

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Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

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