IGBA commentary on FDA’s Draft Guidance on Labeling for Biosimilar Products
Brussels, June 3, 2016 – IGBA thanks the Agency’s for providing an opportunity to comment on the Agency’s Draft Guidance on Labeling for Biosimilar Products (Docket No. FDA-2016-D-0643-0001). IGBA’s position is aligned with the key comments of the Biosimilar Medicines Group, a sector group of Medicines for Europe, which have been submitted separately.