Earlier this week, the FDA took aim at escalating insulin prices that have forced diabetics to ration out the drug as out-of-pocket costs soar. Now, the US Patent and Trademark Office has denied Sanofi’s claim on two patents for its top-selling Lantus, in response to a petition from Mylan, although ongoing litigation between the two companies in US courts could still subvert a potential launch of the generic drugmaker’s copycat version.
Sanofi $SNY, Novo Nordisk $NVO and Eli Lilly $LLY — the trifecta that produce the lion’s share of insulin — have come under pressure in recent years in response to surging prices (the average price of insulin nearly tripled between 2002 and 2013). Revenue from Sanofi’s diabetes franchise, which is down down nearly 30% since 2015, is largely dependent on the insulin glargine injection Lantus. Sales from the long-acting version of human insulin shrank to roughly €1.8 billion (about $2 billion) in the first half of this year.
On Thursday, Mylan $MYL said that the US patent and review board (PTAB) had ruled in its favor, concluding two of Sanofi’s formulation patents were ‘unpatentable’. But last year, the French drugmaker initiated patent infringement litigation against Mylan’s (and Biocon’s) NDA that includes these two formulation patents covering Lantus, as well as other patents covering the Lantus SoloSTAR injection pen.
No date for the ruling has been set yet, although litigation proceedings have ensured that the approval of Mylan and Biocon’s Lantus copycat is subject to a 30-month stay which extends to early 2020.
“We believe that it is unlikely that the PTAB ruling on the formulation patents will have an impact on Mylan’s timing for a launch of its glargine products. The PTAB decision alone does not affect the existing 30-month stay and Mylan does not have tentative FDA approval for its products at this time,” a Sanofi spokeswoman told Endpoints News in an emailed statement.
Aside from pricing pressure, Lantus is already suffering from competition from Lilly’s Basaglar, which was launched in late 2016, after the settlement of a similar case with Lilly the preceding year. CVS and United Health have replaced Lantus in favor of Basaglar in their formularies.
The situation with insulin — as pointed out by Scott Gottlieb earlier this week — is infinitely complex. Although they are technically biological products – that hit the market decades ago – they are classified as drugs and approved via NDAs, thwarting the development of biosimilars. Instead, companies like Lilly and Mylan have developed or are developing what are called follow-on biologics, which are essentially copycat versions of the product, but are not substitutable with the branded product.
Merck and partner Samsung Bioepis, meanwhile, elected to halt the development of their Lantus follow-on biologic earlier this year.
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