Celltrion Submits Denosumab BLA to FDA: On November 30, 2023, it was reported that Celltrion had completed submission of its application to the FDA for CT-P41, its denosumab biosimilar of Amgen’s PROLIA and XGEVA....more
On November 16, FDA approved Eli Lilly’s REZVOGLAR (insulin glargine-aglr) as the second interchangeable biosimilar to LANTUS (insulin glargine), joining SEMGLEE (insulin glargine-yfgn), which was previously approved as...more
On June 7, 2022, from 9:30-10:50 AM Eastern Time, FDA is hosting, virtually, its annual public meeting for public comment on Financial Transparency and Efficiency of the Prescription Drug User Fee Act (PDUFA), Biosimilar User...more