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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.
Consequences of the IRA for the pharma sector
Navigating Pharma’s Evolution: Dive into the consequences of the Inflation Reduction Act 2022. From drug refunds to taxes, Medicare changes, and R&D impacts, the industry is transforming. Stay competitive with our tailored resource solutions. Contact us to thrive amidst evolving pharmaceutical dynamics.
Rare Diseases – Orphan drugs- innovative- models of procurement for rare diseases- pricing and reimbursement in Latin America
Orphan drugs used to treat rare diseases have been labeled “orphan drugs” because of their applicability to very small populations, and they respond to public health needs
Biosimilars in Peru
In Peru, it is necessary to implement criteria regarding the nomenclature of biosimilar medicines and the use of identifiers that allow them to be distinguished from the innovative medicine.
Biosimilars in Mexico
The regulatory body for the approval of
medicines in Mexico is the Federal Commission for Protection Against Health Risks (COFEPRIS)
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