Lilly/BI submit insulin glargine formulation in the US; 505(b)(2) application will allow inclusion of reference data from Sanofi's Lantus - December 21, 2013

Lilly announced yesterday that it, along with Diabetes Alliance partner Boehringer Ingelheim (BI), has submitted the new insulin glargine formulation LY2963016 in the US. The new drug application (NDA) was filed under the 505(b)(2) pathway, which allows for the inclusion of clinical data from an already-existing reference product (in this case, Sanofi's original insulin glargine [Lantus]) in addition to the sponsor's own data on the candidate). Lilly/BI's phase 3 clinical trial program for LY2963016 was conducted in both type 1 and type 2 diabetes patients, using Sanofi's Lantus as a comparator. In July, Lilly/BI submitted LY2963016 in Europe through the biosimilar regulatory pathway, placing a likely EU decision in 2014. According to Lilly management, if the formulation is approved in the EU, it could be launched in 2015, the year when Sanofi's Lantus loses patent exclusivity. Sanofi is currently developing its own new U300 glargine formulation, and recently released topline data from the phase 3 EDITION III, IV, and JPI studies (read our report for more details). Lots of new insulin products coming that we think will keep the field quite interesting; we hope that alongside this, those at lower socioeconomic levels that need access but lack insurance will have high quality products that are easier to obtain. Back on the branded products front - the U300 insulin glargine has demonstrated comparable A1c reduction to Lantus, and in some (but not all) phase 3 studies has shown a benefit in terms of severe and confirmed nocturnal hypoglycemia. If further study confirms the hypoglycemia benefit, it could provide a valuable competitive edge against Lilly/BI's newcomer, though Lilly as the inventor of insulin will undoubtedly have some moves up its sleeve to gain share - and also, we know more and more people are eventually going onto insulin (though when they are doing so is a big question - to learn more about type 2 patients and insulin timing, contact - he runs a panel of 10,000 patients at our sister company that looks at these questions). Lilly management discussed LY2963016 in depth during its Investor Community Meeting in October of this year (read our report), stating that the candidate will likely be introduced as a branded option. Management also forecast that the device expertise, manufacturing capacity, distribution infrastructure, and provider relationships needed to successfully produce and market an insulin glargine biosimilar would slow the rush of me-too candidates to the market. The more we learn on biosimilars, the more we think the devil will be in the details - anyone that has too much conviction on any front related to this area may be in for a surprise.