The question of interchangeability for biosimilars has haunted the US Food and Drug Administration since the promulgation of the Biologics Price Competition and Innovation Act of 2010. The FDA’s draft guidelines on interchangeability evolved very slowly, and the biosimilar industry had to work to (1) keep up with the guidelines as they gained clarity, (2) … Continue reading Biosimilar-to-Biosimilar Switching: The Data Say Its Fine
Tag: Hillel Cohen
More From GRx+Biosims on Four-Letter Suffixes and Biosimilar Interchangeability
The talk at the GRx+Biosims 2018 meeting this month in Baltimore was about challenges, but extrapolation was not one of them. Biosimilar interchangeability was. That was not entirely surprising. In market research projects I’ve been involved with over the past year, payers and physicians in medical groups have broadly indicated that they’ve gotten past the … Continue reading More From GRx+Biosims on Four-Letter Suffixes and Biosimilar Interchangeability
Scaling the Mountains to Create a Biosimilar Market Success
One of the persistent themes at the Association for Accessible Medicines’ first GRx+Biosims meeting was an existential one. Authorities such as Gillian Woollett, PhD; Hillel Cohen, PhD; and several industry experts worried that without a change in mindset and intervention by government, payers, and the industry itself, the US biosimilar industry may not survive its … Continue reading Scaling the Mountains to Create a Biosimilar Market Success