Merck & Co has joined the bid to grab a slice of the market for Sanofi’s big-selling diabetes drug Lantus by licensing a biosimilar candidate originally developed by Korea’s Samsung Bioepis.
Merck first announced its collaboration with Samsung a year ago, revealing that the two companies would be working on a number of biosimilar candidates but declining to reveal their identity.
Now, the two firms have confirmed that the lead project will be MK-1293, a biosimilar of Sanofi’s basal insulin Lantus (insulin glargine), which is the French company’s top-selling drug with turnover rising nearly 19 per cent to €5.72bn ($7.8bn) last year.
Sanofi has already been forced to file a lawsuit against Lilly and partner Boehringer Ingelheim to block approval of their Lantus biosimilar in the US, where the patent for insulin glargine nominally expires in 2015.
It is to be expected that Sanofi will also file a patent infringement suit against Merck and Samsung if their biosimilar nears registration, prompting an immediate 30-month injunction on launch.
The French company is hoping to be able to bring its Lantus follow-up U300 – which promises to have less potential to cause hypoglycaemia than its parent product – before it loses market exclusivity for its top-seller.
Despite being launched onto the market in 2000, Lantus has proved remarkably resistant to competition, with a largely unchallenged position in the market until the approval last year of Novo Nordisk’s rival basal insulin Tresiba (insulin degludec).
Lantus’ security was reinforced after the US FDA turned down Tresiba last year – delaying it for up to two years – and the next-nearest competitor is Lilly and Boehringer’s LY2605541 (insulin peglispro), which is in phase III trials.
Insulin glargine biosimilars could prove disruptive to Lantus as, Tresiba and LY2605541 – as well as Novo Nordisk’s $2bn-a-year long-acting insulin Levemir (insulin detemir) – as they are likely to be priced at a 15 to 20 per cent discount and should win a hefty slice of market share.
Credit Suisse predicted recently that Lilly and Boehringer’s biosimilar could become a $1.4bn product by 2020, adding that basal insulins will continue to dominate the diabetes market in the coming years.
“We look forward to collaborating with Samsung Bioepis on this insulin glargine candidate, as diabetes is a top priority for the company,” commented Matt Strasburger, senior vice president for diabetes at Merck.
The company is developing oral sodium glucose co-transporter (SGLT2) inhibitor ertugliflozin in phase III and also has an oral, once-weekly DPP-4 inhibitor – omarigliptin – in mid-stage testing.