Similar biotherapeutic products approved and marketed in Latin America

Last updated: 8 November 2013

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

For example, in recent years, ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) in Argentina, ANVISA (Agência Nacional de Vigilância Sanitária) in Brazil and COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) in Mexico have developed their own abbreviated regulatory pathways for similar biotherapeutic products, by merging World Health Organization (WHO) and European Medicines Agency (EMA) guidelines for biosimilars to suit their own political and economic needs.

To date, similar biotherapeutic products for rituximab and etanercept have been approved for marketing in Latin America, see Table 1.

Table 1: Similar biotherapeutic products approved and marketed in Latin America

Product name	Active substance	Therapeutic area	Countries marketed	Company	Latin American partner
Etanar	etanercept	Ankylosing spondylitis Arthritis Psoriasis	Colombia	Shanghai CP Goujian	LaFrancol
Kikuzubam	rituximab	Rheumatoid arthritis Non-Hodgkin lymphoma Leukaemia	Mexico	Probiomed	Not applicable
Reditux/ Tidecron	rituximab	Rheumatoid arthritis Non-Hodgkin lymphoma Leukaemia	Bolivia, Chile, Ecuador, Paraguay^†, Peru	Dr Reddy’s Laboratories	CF Recalcine (Chile) Western Pharmaceutical (Ecuador)* Farmindustria (Peru)* FAPASA (Paraguay)
^†approved via ‘generics’ pathway; *Western Pharmaceutical and Farmindustria are subsidiaries of CF Recalcine.

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 article

Biosimilars approved in Europe

Source: www.gabionline.net

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