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 |
Colombia |
Shanghai CP Goujian |
LaFrancol |
|
Kikuzubam |
rituximab |
Rheumatoid arthritis |
Mexico |
Probiomed |
Not applicable |
|
Reditux/ Tidecron |
rituximab |
Rheumatoid arthritis |
Bolivia, Chile, Ecuador, Paraguay†, Peru |
Dr Reddy’s Laboratories |
CF Recalcine (Chile) |
|
†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
