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Lantus Follow-On Basaglar OK'd, But Can Lilly Sell It?

 
• By Donna Young

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.

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.

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