Objective:

To determine the essential aspects of the Costa Rican regulation concerning the sanitary registration of biosimilars and to compare them with the information provided in the dossiers of laboratories manufacturing heparin and enoxaparin.

Methodology:

The regulation for the Registration and Control of Biological Drugs: RTCR 440: 2010 was reviewed. Subsequently, the dossiers sent by the manufacturers were requested, and their information was compared with the data requested by the previous regulation. Finally, the importance of this information was evaluated.

Results:

The national regulations require chemical, pharmaceutical and biological information on the finished pharmaceutical product, results on safety and efficacy, administrative data and legal documentation. For biosimilars, the biosimilitude exercise and a pharmacovigilance plan must be presented. This information is not available in its entirety in the reviewed dossiers.

Conclusions:

The products reviewed do not meet the requirements of the Costa Rican regulations regarding the biosimilitude exercise. Therefore, they were not submitted for their drugs' applications before the Ministry of Health of Costa Rica.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )