US FDA’s first decision on biosimilars interchangeability might have less meaning for two insulin products, but payer and prescriber responses to interchangeable biosimilars for adalimumab, which are further out on the horizon, may be more instructive regarding the importance of interchangeability status.

The European Medicines Agency is meeting this week to consider applications to broaden the use of approved drugs to include new indications in the EU. 

The company's pharma chief Marie-France Tschudin does not expect Entresto's "unique position" in heart failure to be threatened by SGLT2 inhibitors such as Jardiance and Farxiga, saying those drugs are add-ons that will be used predominantly in diabetes patients.

More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.