OBJECTIVES:  In spite of the globalization of the pharmaceutical industry, differences exist in the number and characteristics of the pharmaceutical products available in each country. This study compared the pharmaceutical products approved in the US and registered in Peru as of December, 2013, and assessed differences in approvals of chemical entities, therapeutic biologics and orphan drugs, and generic entry.  METHODS: Information about pharmaceutical products approved in the US and Peru was obtained from the US Food and Drug Administration (FDA), and the General Directory of Medicines, Supplies, and Drugs of Peru (DIGEMID), respectively. Descriptive statistics and chi-square tests were performed in the analysis. Significant level was set at 0.05.  RESULTS: A total of 2,409 approved pharmaceutical products were listed by the FDA as of December, 2013 of which 763 (31.7%) were also registered by DIGEMID, including 39.1% of generic multisource products and 25.1% of brand single source products. A total of 112 biologic products were listed by the FDA and 64 (57.1%) were also registered in Peru. There were 368 products with orphan indications approved by the FDA and 112 (30.4%) were also registered in Peru. Generic competition was available for 46.8% of the products approved by the FDA and 57.8% of the products approved by DIGEMID (p<0.001).   CONCLUSIONS:  Peru has substantially less pharmaceutical products approved than the US, especially for brand products without generic competition and orphan drugs. The highest percentage of products approved in both countries corresponded to therapeutic biologics. Part of the differences in drug approvals can be explained by variations in the epidemiological profile of both countries. The relatively small size of the Peruvian pharmaceutical market and limited purchasing power may result in reduced incentives for pharmaceutical companies to register new molecular entities and products for orphan diseases in Peru.