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

Source URL: https://gabi-journal.net/news/similar-biotherapeutic-products-approved-and-marketed-in-latin-america


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