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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.
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 Argentina
The country is currently an important producer of biopharmaceuticals, and for this reason, there are incentivization policies for the development of biosimilars…
Biosimilars in Chile
The regulatory body in charge of approving
medicines is the National Medicines Agency (ANAMED), which is part of the Public Health Institute of Chile (ISP), under the Ministry of Health.
Colombian Health System
The main objective is to regulate the essential public health service and create conditions of access for the entire resident population of the country, at all levels of care.