Memorandum
Sanofi and Lilly announced this morning that they have reached a settlement agreement in the US patent lawsuit over Lilly/BI’s insulin glargine formulation Basaglar, which had been scheduled to go to trial today. Under the terms of the agreement, Lilly will pay undisclosed royalties to Sanofi in exchange for the license to disputed patents for Lantus (insulin glargine). Lilly and partner BI will be able to launch Basaglar in the US on December 15, 2016 pending final FDA approval, which Lilly plans to request shortly – the original expectation was for full approval in mid-2016 unless the case was resolved earlier in Lilly’s favor. The FDA tentatively approved Basaglar in August 2014, and we assume that this lawsuit was the only hurdle standing in the way of full approval. Even with the delay, Basaglar should be the first “biosimilar” insulin to reach the US market (it is not technically designated as a biosimilar by the FDA but has an identical amino acid sequence to Lantus and has demonstrated clinical equivalence in phase 3 trials). The product has already launched in Japan and several European countries, most recently in the UK, under the trade name Abasaglar. The arrival of insulin biosimilars is expected to offer somewhat of a respite from the rising insulin prices that have led to so much frustration among patients and providers, though the size of the discount remains a major unanswered question. So far Abasaglar has been priced at a 15-20% discount vs. Lantus where it has launched, though we wonder if the discounts could be steeper in the US given the significantly higher prices for branded basal insulin analogs. Another major question is how much confidence physicians will have in the safety and clinical equivalence of biosimilar insulins – see our detailed report on Basaglar’s tentative approval for more.