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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 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.

Mexican Health System
To establish state policies so that the
population has the right to health protection.

Rare Diseases current situation in Latin America and the global drug market
The size of the global market in 2021 for the treatment of rare diseases was valued at USD 119.600 million it is expected to increase at a compound annual growth rate (CAGR) of 12.8% between 2022 and 2030.

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 Brazil
Brazil has designed a set of measures to increase investment in biopharmaceutical research and is promoting the production of national biological drugs.