Brazil

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

Celltrion’s adalimumab biosimilar was crowned as interchangeable by the FDA, at a time when the future of the designation is unknown.

The divestment marks a further step in Fresenius’ ongoing strategy towards a more optimized and simplified company structure while doubling down on new endeavors in the Biopharma space.

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.

Speaking as Hypera delivered its full year-results, CEO Breno Oliveira has set out plans for the Brazilian firm to launch an Ozempic rival in its domestic market next year. Meanwhile, the company is dealing with increasingly aggressive local generic competition.

Brazil’s drug regulator ANVISA has also published its first post-marketing authorization monitoring reports on advanced therapies Yescarta, Zolgenma, Kymriah, Carvykti and Luxturna.

India’s Torrent managed to register growth in its financial third quarter – despite being hit by severe currency headwinds in Brazil and suffering a decline in the US – as growth in Germany and its domestic market more than offset the damage.

As Torrent joins Indian majors with plans to launch semaglutide in India and Brazil post patent expiry, market access topics like price and demand come up for discussion. Meanwhile, the supply chain is seen overcoming shortages

Only days after its initial announcement, Hypera Pharma has refused EMS’ proposed merger on grounds of undervaluation and different strategic priorities.