Biosimilars Guidance On Interferon Beta From EMA Foreshadows Possible Joint EU/U.S. Approach
This article was originally published in The Pink Sheet Daily
EMA’s biosimilars interferon beta guideline, which says that magnetic resonance imaging of disease lesions may be enough to demonstrate similarity. More important perhaps, it’s the first guidance issued under the watch of new EMA chief Guido Rasi, who strongly supports allowing single data package for EU and U.S. biosimilar medicines.
You may also be interested in...
IQWiG’s failure to find any added benefit from Novartis’ oral MS drug Gilenya in two out of three of its target patient groups, on the grounds of insufficient evidence, puts pressure on the drug following a similarly negative recommendation by U.K. cost-watchdog NICE at the end of 2011.
Short public meeting on the biosimilar user fee agreement suggests the proof will be in the scheduling.
Agency interactions with sponsors under BsUFA are not dependent upon opening an IND. Sponsors may be able to demonstrate similarity to an FDA-licensed reference product by bridging to foreign clinical data, Associate Director for Biosimilars Leah Christl says.