This paper aims to describe the health implications with the use of biosimilars compared with biological drugs in Colombia. Also, described the regulatory context about the use of biosimilars, recommendations and guidelines on safety and effectiveness of using biosimilar and biological medicines, based on their biomolecular differences. For this, an electronic document review and manual literature databases, magazines and books limited MeSH terms was developed. The selection of items included full papers published in indexed journals from last 10 years, in Spanish and English; the information collected was organized for the construction of this document. In conclusion, we found that many biological drugs patents have expired or are close to expiring and several biosimilars are being developed and marketed even in countries without strict regulations. Biosimilars can never be equal to the original by their molecular complexity, so we must integrate pharmacovigilance systems to improve traceability and identify their origin while distinguishable nonproprietary names are set. Current evidence suggests that regulation of biosimilar medicines should be evaluated and harmonized worldwide.
