Regulation of similar biotherapeutic products in Latin America

Biosimilares/Investigación | Posted 02/08/2013 post-comment2 Post your comment

Regulation of similar biotherapeutic products (SBPs) 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 [1, 2].


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 less costly 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 SBPs, see Table 1.

Table 1: Similar biotherapeutic products regulations in Latin America

Country Name for biosimilars Regulatory authority Relevant law Year of publication Issues left to discretion of regulatory authority
Argentina Medicamento biológico similar (similar biological medicines) Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) Legislation numbers 7075 and 7729 2008  
Bolivia Not stated Ministerio de Salud y Deportes No regulation    
Brazil Follow-on biological products Agência Nacional de Vigilância Sanitária (ANVISA) Resolution no. 55/2010 2010 - Type of studies
- Other requisites
Chile Biosimilares (biosimilar) Agencia Nacional de Medicamentos (ANAMED) Regulations of the National System for the Control of Pharmaceutical Products for Human Use D.S. 3/2010 Draft guidance 2011 - Type of studies
- Extrapolation to other indications

Medication of successor biological origin


Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) Ministerial Decree 677/1995 Draft guidance 2013  

Costa Rica


Biosimilar medication Ministerio de Salud Decree no. 37006 2012 - Whether to use another guideline in some circumstances
Cuba Known biological product Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED) Resolution no. 56/2011 2011  
Guatemala Biosimilar/biocomparable Ministerio de Salud Pública y Asistencia Social Technical standard 67-2010 2010  

Biocomparables (biocomparable)

Biotechnological medicine


Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) Article 222 bis in the Mexican Health Law (Articule 39 de la Ley Orgánica de la Administración Pública Federal y 222 Bis de la Ley General de Salud) 2012

- Need for clinical studies
- Type of studies




Not stated Ministerio de Salud Panama (MINSA) Executive Decree no. 340 2007  
Peru Producto biológico similar (similar biological product) Ministerio de Salud Peru (MINSA) Supreme Decree no. 016-2011-SA 2012  

The trend in Latin America is to adopt guidelines for similar biotherapeutic products 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 [2].

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 SBPs approved in the region.

Editor’s comment
It should be noted that similar biotherapeutic products approved in Latin American countries 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 productos biológicos similares

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


1.  Mysler E, Scheinberg M. Biosimilars in rheumatology: a view from Latin America. Clin Rheumatol. 2012;31(9):1279-80.

2.  Desanvicente-Celis Z, Caro-Moreno J, Enciso-Zuluaga M, Anaya JM. Similar biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases. Biosimilars. 2013;3:1-17.

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comment icon Comments (2)
Post your comment
Posted 25/10/2013 by Jodi H, GaBI Online Editorial Office
Response to ‘Biosimilars in Peru’

Dear Dr Vásquez,

Thank you for providing your insight and knowledge on the subject. As such, we would be delighted if you would consider submitting a paper to GaBI Journal on this topic.

If interested, please feel free to reach us at

Thank you again and we hope to hear from you soon.

Best regards,

Posted 05/08/2013 by Hans Vásquez,MD. DIGEMID. Ministry of Health
Biosimilars in Peru

In Peru the name of biosimilars is "Producto Biológico Similar" (Similar Biological Product). The supreme decree have general aspects about requirements of biosimilars products. Actually there is a draft with specific requirements to biotechnological and similar biological products on this link:

Thank you, Hans

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