EU Pharma Package Sets Nine Years’ Default Protection and Rewards Comparative Trials With a Tenth
The default gets shorter, and the route back to the maximum runs through comparative trials and filing early in Europe.
Generics
Teva Faces New Probe in Turkey Over Conduct Flagged by EU
Not a new theory of harm. It is the European Commission’s Copaxone decision run a second time, with two of the same corporate entities named.
Brazil Approved Five Semaglutides in a Day. Sandoz Announced One of Them.
ANVISA approved five semaglutide products in a single day, including the one Sandoz will sell. Ozempic’s Brazilian patent expired in March.
China Stopped Excluding Patented Drugs From Its Price Cuts. Now the Bidder Signs for the Risk.
Eight patent-sensitive molecules were admitted to China’s price-cutting round on one condition: the bidder signs an intellectual property undertaking and carries the risk.
Trump Wants Generics Made in America by 2028. The Economics Say They Can’t.
Trump gave generic drugmakers until August 2028 before a 100% tariff, rising to 200% in 2029. The problem is the margin those drugs actually carry.
Spain rewrites its drug-pricing rulebook, and the price of a generic will now fall as it sells more
Spain’s new draft Medicines Law will cut the price of generics and biosimilars automatically as their market share grows, replacing a system where prices froze after one initial discount.