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Orphan drugs in Latin America: the case of eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome
Eculizumab It has been used in the treatment of orphan diseases, such as paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), neuromyelitis optica spectrum disorder (NMOSD) and myasthenia gravis
Biosimilars in Mexico
The regulatory body for the approval of
medicines in Mexico is the Federal Commission for Protection Against Health Risks (COFEPRIS)
Biosimilars in Latin America
The regulations for biosimilars vary
considerably from one country to
another, but in general the trend is an
increase in the regulatory standards for their health registration.
Mexican Health System
To establish state policies so that the
population has the right to health protection.
Biosimilars
It is a biological medicine that contains a
version of the active ingredient of an original biological product (reference product) whose patent has expired.
Health System in Ecuador
The Ministry of Public Health (MSP) offers health care services to the entire population.

