Brazil
Country
Brazil’s EMS has agreed to acquire Sanofi’s Medley generics business in a deal aimed at strengthening its position in the country’s off-patent medicines market, with the combined platform potentially reaching about 32% share pending regulatory approval.
Sandoz says GLP-1s represent a long-term growth opportunity but warns the off-patent market will take time to develop, with early launches potentially coming in Canada and Brazil as the company tests supply dynamics and regulatory timelines.
Moves to issue a compulsory license for Lilly’s GLP-1tirzepatide products Mounjaro and Zepbound come as Brazil prepares to make its own versions of Novo Nordisk’s semaglutide and liraglutide.
The Brazilian government wants to boost the country’s capabilities to develop radical innovation that leads to new therapies for the national health system.
Two major EU trade agreements are on hold, with ramifications for the pharmaceutical market.
Brazilian authorities say that some pharmaceutical companies exploit court cases brought by patients to secure drug access to achieve higher prices.
Brazil’s new drug pricing rules, which come into force in April, are intended to better recognize incremental innovation and give more predictability to the pricing of biosimilars.
Anvisa, the Brazilian medicines regulator, has published a new Q&A document relating to clinical research requirements. Meanwhile, the regulator’s new innovation committee, set up to monitor and evaluate innovative products, has set out its key priority areas.
Licensing agreement expands Polpharma’s footprint in Latin America while supporting Libbs’ strategy to grow access to advanced biologics in Brazil.
Brazil’s medicines regulator, ANVISA, has hired new staff to help halve the time it takes to register a new medicine in Brazil.
Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.
A new decree in Brazil establishes a new ethics governance and operational structure in clinical research and seeks to better protect clinical trial participants.