The FDA’s rejection of Acadia’s label expansion into a broader patient population for its only approved drug resulted in an aggrieved reaction. Better disclosure from both sides would have helped.

The rise of the biosimilars has been predicted for many years, but the commercial dynamics after complex biologic drugs’ loss of exclusivity suggests that it may not be so straightforward.

Amphastar’s 2020 financial results included its best ever quarter and a different revenue pattern from most pharma and generic companies. Its evolving product mix and marketing campaigns were two reasons for its performance.