FDA’s observations at Aurobindo subsidiary Eugia's plant in India and a new one in New Jersey could lead to more drug shortages in the US, particularly injectables, though the company aims to streamline production by end-March. Meanwhile, it will capitalize on the “sizable opportunity” from the EU's list of critical medicines while launching a Herceptin biosimilar in India

Intas – the the troubled Indian firm at the center of the cisplatin shortage – may have punished workers for their visual-inspection subterfuge, but it also should have gone after managers, the FDA asserted in a second data integrity warning letter in four months.

Intas and mAbxience have announced an exclusive licensing agreement covering mAbxience’s etanercept biosimilar candidate in more than 150 countries worldwide, including Europe and the US.

In a year that has seen significant changes throughout the generics and biosimilars industry ranking, the top 10 has welcomed two Indian off-patent leaders. Meanwhile, companies lower down our ranking have enjoyed mixed fortunes, leading to a number of significant movements in this year’s Generics Bulletin Top 50.