The Food and Drug Administration has approved Eli Lilly's long-acting insulin Rezvoglar as an “interchangeable” product with Sanofi’s Lantus, making it the second insulin biosimilar to receive the valuable designation.
The approval comes a year and a half after Viatris and Biocon’s Semglee became the first insulin biosimilar to receive interchangeable status, securing 12 months of exclusivity before the FDA could add the tag to another copycat competitor.
The FDA previously approved Rezvoglar as a biosimilar to Lantus in December 2021. To qualify as interchangeable, Lilly had to show the clinical benefits would be the same as Lantus and there would be no risks or loss of efficacy for patients who switch from Lantus to Rezvoglar.
Akin to generics for pharmaceutical pills, biosimilars are highly similar to biologic drugs. Without the interchangeable designation, however, they can’t be automatically substituted by pharmacists.
There are several long-acting insulins available on the market, and the availability of Semglee and Rezvoglar now give patients and providers further choice. The added competition could act as another lever for insurers to control insulin costs in the U.S., which have drawn the criticism of lawmakers and the public for years.
Congress capped out-of-pocket costs for insulin for Medicare enrollees starting in 2023, after falling short of the votes to do the same for private insurance. Drugmakers have also started to respond to the criticism in recent years, and taken steps to lower out-of-pocket insulin costs for patients.
But those efforts did not prevent the public fury ignited by a tweet from a fake blue-checked Twitter account last week that claimed Lilly would make insulin free. In his first remarks defending the company since the tweet, Lilly CEO David Ricks this week said many claims confuse the 100-year-old version of the drug for newer, long-acting forms and do not consider affordability programs that reduce co-pays.
“It probably highlights that we have more work to do to bring down the cost of insulin for more people,” he said at a Stat News event.
For the nine months from January through September, Sanofi reported that Lantus revenue in the U.S. fell 9.2% — to 642 million euros, or $665 million — compared to the same period last year. The company said U.S. sales have been impacted by formulary losses as well as erosion of the long-acting insulin market.
FDA-approved biosimilars with interchangeable designation
|Biosimilar||Manufacturer||Reference product||Designation approved|
|Semglee||Mylan, Biocon||Lantus||July 2021|
|Cyltezo||Boehringer Ingelheim||Humira||Oct. 2021*|
|Rezvoglar||Eli Lilly||Lantus||Nov. 2022|
*Cyltezo is not yet available commercially. Source: FDA, companies