South America

Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.

CMED, which sets medicine prices in Brazil, has published the maximum price adjustment index for 2025.

The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.

Cipla has bolstered its ophthalmology portfolio and increased its global offering after chalking up an agreement to add Formosa Pharmaceuticals’ USFDA-approved clobetasol propionate 0.05% ophthalmic suspension.

Chinese biosimilars developer Bio-Thera is expanding its Latin American partnership with SteinCares with the addition of a third product.

Lupin has added two ADHD drugs to its Canadian portfolio, while also signing multiple branded deals in other global markets.

Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.

Generics Bulletin recaps the most recent regulatory news from across the world.

Regulators in Europe and the US have demonstrated a commitment to providing guidance that will make decentralized and point-of-care manufacturing a reality, the CSO of GermFree, a company that provides mobile and modular cleanrooms for manufacturing advanced therapies, tells the Pink Sheet.

Fresenius Kabi has completed the divestment of its Chilean subsidiary Laboratorio Sanderson to Peru’s Medifarma, including the transfer of an IV drug facility in Santiago de Chile, as part of streamlining the German group’s manufacturing operations.