PP_1170x120_10-25-21

Eva Temkin is a partner in King & Spalding’s FDA & Life Sciences practice. She can be contacted at etemkin@kslaw.com

Fulfilling interchangeables’ promise will take work

Fulfilling interchangeables’ promise will take work

Pharmacy-substitutable biologics, known as interchangeables, have long been little more than an idea. Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) created a dual pathway for follow-on biologics — with biosimilars that are prescribed by name by a health care provider and interchangeables that can be automatically substituted at the pharmacy —