Lantus Follow-On Basaglar OK'd, But Can Lilly Sell It?
Eli Lilly & Co. and its partner Boehringer Ingelheim GmbH won the first-ever US approval of a follow-on version of Sanofi SA's Lantus (insulin glargine) – a clearance for marketing that was permitted under the FDA's 505(b)(2) abbreviated pathway, which permits an application to rely, in part, on safety and efficacy data from an innovator's product.