South America

Prestige Biopharma has picked Biosidus to manufacture and export its Tuznue biosimilar rival to Herceptin across four Latin American countries.

Argentina’s medicines regulator, ANMAT, is updating the national pharmacopeia with new guidelines on advanced therapies.

Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.

New rules in Argentina mean that good manufacturing practices certificates for foreign drug manufacturing plants issued by certain regulatory authorities could lead to quicker GMP certification evaluations.

A new decree in Brazil establishes a new ethics governance and operational structure in clinical research and seeks to better protect clinical trial participants.

Argentina has implemented a nation-wide traceability system for medicines for the first time.

Brazil is planning to update its National Clinical Research Action Plan to make the country a more competitive location to conduct R&D.

Brazil is planning to update its National Clinical Research Action Plan to make the country a more competitive location to conduct R&D.

Two of Latin America’s biggest regulators have signed a memorandum of understanding to deepen cooperation and improve access to medicines.

Roberto Khoury, Perrigo’s international lead for a year, moves to CCO while his counterpart for the Americas region appointed in September 2023, Catherine "Triona" Schmelter, is leaving with her post eliminated in the firm’s changes.

Bio-Thera Solutions is back with its third agreement with Costa Rica-based SteinCares for the supply of a biosimilar in Latin America – this time for the Chinese firm’s proposed rival to Sanofi and Regeneron’s Dupixent (dupilumab)

There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.