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.

Conventional wisdom from the first biosimilar launches was that the European market that was far tougher on innovator products than was the US. More recent data suggest that things may play out differently in the long run.

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.

Leaving the validation of a drug target until the end of Phase III studies is risky, but working on the unvalidated targets identified by others is riskier still.

The licensing or self-commercialization decision can be important for the success of a biotech company, but do other more fundamental factors concerning the drug dictate a company’s success?