High costs and limited access have prevented some governments from investing in biotechnology products. However, as more biosimilars are introduced to the market, a growing number of Latin American countries are approving these advanced medicinal products, providing their populations with access to drugs that have revolutionized the treatment of some chronic diseases.
The US Food and Drug Administration (FDA) defines a biosimilar medicine as a biological product highly similar and with no clinically significant differences from the reference product already approved by the FDA, while the definition from the European Medicine Agency (EMA) is a medicine highly similar to other biotechnological product already approved. In addition, the World Health Organization has developed a prequalification program to help countries that lack a rigorous regulatory framework.
Recognizing the advantages biosimilars present, a growing number of Latin American countries have started to invest in these medicines.