With an FDA nod for its copycat of Eli Lilly's popular Humalog insulin, Sanofi is one step closer to challenging blockbuster diabetes sales from its rival. Sanofi's Admelog is the first meal-time insulin copy the FDA has approved.
Sanofi's Admelog picked up a final FDA nod on Monday after being granted a tentative approval back in September. The company plans to launch in early 2018 and will provide pricing information then, according to a spokesperson. Admelog is a fast-acting insulin designed to help people with diabetes manage their blood sugar at mealtime.
At the time of the initial approval, Bernstein analyst Tim Anderson noted that Eli Lilly's Humalog patent protections have run out, but that the Indianapolis drugmaker could try to win an extra 2.5 years of protection by suing for infringement on its remaining patent covering the KwikPen injection device. The drawback of the strategy, however, is that the company could face trouble for filing a frivolous lawsuit, Anderson wrote.
A spokesperson for Sanofi told FiercePharma that Admelog will be available in early 2018 and that there are no ongoing patent disputes between the companies.
"We will be providing more specifics about pricing when the product is available," she added.
At stake with Sanofi's launch is $1.685 billion in U.S. sales and $2.7 billion in global sales for Humalog, both full-year figures from 2016. Sanofi's Admelog won European approval as a biosimilar back in July.
Sanofi will also have a chance to get back at Lilly for the Lantus copycat its rival launched late last year. Lilly's Basaglar has had some success so far on the market, generating $278 million in the first 9 months of 2017. Still, the figure pales in comparison to Lantus' $4.16 billion in global sales this year.
An Eli Lilly spokesperson told FiercePharma "we always believe that multiple treatment options are important for people with diabetes."
Admelog is expected to find a ready market once it launches. A Barclays survey this year found that 42% of respondents expect to write scripts for the medication once it arrives, versus just 10% who thought they’d prescribe Basaglar. One reason is that the rapid-acting insulin market is far more concentrated, with Humalog and Novo Nordisk’s NovoLog holding most of the market.
As competition in diabetes has ratcheted up in recent years, both drugmakers—and fellow diabetes drug maker Novo Nordisk—have seen sales suffer and resorted to job cuts to offset challenges. Lilly recently embarked on a round of 3,500 layoffs as it looks to cut costs. Sanofi led Big Pharma in job reductions for 2016, according to EP Vantage, while Novo Nordisk chopped 1,000 positions in September 2016.
The new approval—which came under an abbreviated regulatory pathway—comes amid a push at the FDA to bolster competition in the market as a way of lowering drug costs. Shortly after taking the position, FDA Commissioner Scott Gottlieb, M.D., made that one of his goals.
“In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways," Gottlieb said in a statement on Monday.