Biosimilarity in Latin America

The introduction of new legislation in Latin America for the approval of biosimilar products follows implementation of EU legislation in 2005 for biosimilars approval. The establishment of regulatory processes for these complex drugs will ensure that evidence of safety and efficacy is obtained before approval. Biosimilars are high on the health-policy agenda because they are less costly and potentially more accessible, and also because of the imminent expiration of a number of patents on biological products. Within individual Latin American countries, the regulatory processes and stages of implementation vary.