Sanofi-Lilly Settlement Paves Way For Biosimilar Lantus
This article was originally published in Scrip
A potential launch of Eli Lilly & Co.'s copycat version of Sanofi's blockbuster Lantus (insulin glargine) in 2016 will put pressure on the entire insulin category, including new drugs like Novo Nordisk AS's Tresiba (insulin degludec) and Sanofi's own follow-on Toujeo.
The launch of a biosimilar-type product in the US next year looks likely now that Lilly and Sanofi announced a settlement agreement in an ongoing patent dispute on Sept. 28. As part of the agreement, Lilly and its partner Boehringer Ingelheim GMBH can launch the product named Basaglar on Dec. 15, 2016. Lilly will pay Sanofi royalties, though the details of the agreement were not disclosed.
The timeline is on track with what many industry observers have been anticipating, after Sanofi filed a patent infringement lawsuit against Lilly in January 2014, triggering a 30-month stay of action by FDA until at least mid-2016. A positive ruling in the court case would have opened the door for a slightly earlier launch, however.
The diabetes market – and particularly insulin – has come under increasing pressure on the reimbursement front, and the anticipation of a potentially cheaper rival already has caught the attention of payers.
Lilly already launched the product in Europe as a biosimilar under the name Abasaglar. In the US, the drug was granted a tentative approval in August 2014 through the 505(b)(2) pathway, which allows drug manufacturers to reference previously approved similar drugs, rather than the new pathway for biosimilars.
Basaglar has the same amino acid sequence as Lantus and was approved for use with KwikPen, the prefilled pen also used to administer Lilly's short-acting insulin Humalog. Basaglar and Lantus are long-acting insulins intended to provide blood sugar control between meals and during the night.
The 505(b)(2) path was taken by Lilly, because although Lantus is considered a complex drug, it was approved as an NDA, not a BLA for biologics. Therefore, Lilly said the 505(b)(2) pathway was the most appropriate. The company has not said how it plans to price the drug in the US, but the general thinking has been that it would be positioned as a biosimilar.
The availability of a cheaper alternative would not only impact sales of Lantus – the top-selling basal insulin in the world – but also could impact the launch of two new long-acting insulins: Novo's Tresiba and Sanofi's Toujeo. Both drugs are linchpins in their respective companies' strategies to bolster their diabetes franchises in the face of increasing competition.
Novo's Tresiba was approved by the FDA on Sept. 25 after a lengthy delay because of cardiovascular safety concerns, but interim data from Novo's DEVOTE cardiovascular outcomes trial assuaged FDA's worries. The agency simultaneously approved a combination product Ryzodeg 70/30, combining insulin degludec and insulin aspart.
The company also announced the NDA filing for Xultophy, a combination of Tresiba with Novo's market-leading glucagon-like peptide-1 agonist Victoza (liraglutide).
Sanofi's Toujeo was approved in February and is positioned as a longer-acting follow-on to Lantus. Sanofi is also looking to file a once-daily, fixed-dose combination of Lantus with its GLP-1 candidate Lyxumia (lixisenatide) in the fourth quarter.
This article is also being published in "The Pink Sheet" DAILY. Scrip Intelligence brings selected complementary coverage from our sister publications to our subscribers.