Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars

Abstract: The US Food and Drug Administration (FDA) proposed eliminating the distinction between biosimilars and interchangeable biosimilars with the stated aim of aligning with European policy and enhance biosimilar uptake. However, this move is misguided as it would result in widespread generic-style automatic substitution at the pharmacy level; which is rare in Europe. Physician confidence […]


Barriers to market uptake of biosimilars in the US

Author byline as per print journal: Joshua P Cohen, PhD; Abigail E Felix, BA; Kim Riggs, MPH; Anumeha Gupta, MD Background: In the US, a new approval pathway for biosimilars has been established as part of the Affordable Care Act. Biosimilars are anticipated to increase treatment options and lower the growth in spending on biologicals. How the commercial […]