Memorandum

Lilly/BI biosimilar insulin glargine receives positive CHMP opinion - June 27, 2014

Lilly announced earlier today that it and BI’s biosimilar insulin glargine formulation LY2963016 received a positive opinion for approval from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of both type 1 and type 2 diabetes. Following EMA precedent, Lilly expects the European Commission’s final decision in about two months. LY2963016 is the first insulin categorized as a biosimilar to be recommended for approval in the EU and, if approved, would be the first biosimilar to reach the EU market. Lilly/BI filed LY2963016 in the US late last year (read our report), and that process was stalled by up to 30 months earlier this year by a Sanofi patent lawsuit (this is still a black box to us on exactly how this works). Merck and partner Samsung Bioepis are also developing a biosimilar insulin glargine, which recently moved into phase 3 testing (read our report). Phase 3 data on LY2963016 presented at ADA demonstrated a fairly identical safety and efficacy profile to Sanofi’s Lantus (see our coverage of the ELEMENT 1 and ELEMENT 2 trials). Lilly shared during its ADA pipeline update call that it expects the biosimilar insulin market to behave more like a branded market. Even so, the introduction of biosimilar insulins will only serve to heighten the pricing pressure in the current insulin market simply by introducing new options, although the next generation of basal insulins such as Sanofi’s U300 insulin glargine Toujeo, Novo Nordisk’s Tresiba (insulin degludec), and Lilly’s novel hepatoselective basal insulin peglispro have the potential to command better premiums and further improve the patient and HCP experiences (and ultimately the payers since they all have potential to improve outcomes, especially when combined with GLP-1 and when patients use them earlier and more aggressively).