A Conversation With Gillian Woollett, MA, DPhil, Senior Vice President, Avalere Health In the conclusion of a two-part conversation with one of the real go-to experts in the biosimilar field and US regulatory process, we talk with Dr. Woollett about the need for a new approach by the FDA when evaluating biosimilar applications. Biosimilars Review … Continue reading A More Useful Way of Evaluating New FDA Biosimilar Applications
Tag: Gillian Woollett
Insulin Transitions: A Dead Zone in the Gap Year, and Other Considerations
An Assessment With Gillian Woollett, MA, DPhil, Senior Vice President, Avalere Health In this two-part conversation with one of the real go-to experts in the biosimilar field and US regulatory process, we talk with Dr. Woollett about the upcoming transition for insulins and other pharmaceuticals in March 2020, when they become regulated as 351(k) biosimilars. … Continue reading Insulin Transitions: A Dead Zone in the Gap Year, and Other Considerations
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
Plans Use Step Therapy to Encourage Utilization of Remicade Over Biosimilars
Health plans and insurers are not yet turning to biosimilar infliximab as a preferred therapy, according to Gillian Woollett, DPhil, MA, of Avalere. Her new report surveyed publicly available policy about health plans across the nation. The principal finding was that step therapy was commonly used to encourage use of the originator product. In fact, … Continue reading Plans Use Step Therapy to Encourage Utilization of Remicade Over Biosimilars