This may be good news for partners Mylan and Biocon: Two bills are circulating on Capitol Hill that can alter the transition of insulins to biologic agents in March 2020. However, the timing for passage of these bills is questionable. The Senate’s Affordable Insulins Approval Now Act (S.2103), a bipartisan bill that was introduced by … Continue reading New Legislative Proposals Offer Hope to Insulin Follow-on Manufacturers
Tag: insulin transition
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