FDA Approves First Follow-On, Fast-Acting Insulin But Impact On Pricing, Access Unclear

FDA approved Monday (Dec. 11) the first fast-acting insulin to go through the abbreviated 505(b)(2) pathway, Sanofi-Aventis U.S.'s Admelog, a follow on to Lilly's blockbuster Humalog. FDA Commissioner Scott Gottlieb praised the approval as a step forward for drug pricing, but how significant of a price cut the product will take relative to its competitor and whether Admelog will be interchangeable with Humalog is unclear. Two top congressional leaders have also cautioned that marketing of products similar to Admelog could...