FDA approves subcutaneous Merilog for glycemic control in diabetes
Key takeaways:
- The drug, which is the first rapid-acting biosimilar, is meant to treat blood sugar spikes at mealtimes.
- With the approval, Merilog joins two other long-acting biosimilar insulin products.
The FDA has approved the first rapid-acting biosimilar insulin product for glycemic control in people with diabetes.
Merilog (insulin-aspart-szjj, Sanofi-Aventis U.S.) was approved as biosimilar to Novolog (Novo Nordisk) for improving blood sugar control for individuals with the condition, according to a press release from the agency. The drug, which is administered via subcutaneous injection, helps lower blood sugar spikes during mealtimes.
The approval applies to both a single-patient-use prefilled three mL pen and a 10 mL multi-dose vial.
“For the millions of people who rely on daily injections of insulin for treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these lifesaving medications,” Sarah Yim, MD, director of the office of therapeutic biologics and biosimilars in the FDA’s Center for Drug Evaluation and Research, said in the release.
Merilog marks the third FDA approved biosimilar insulin product, joining two long-acting products that were approved in 2021. The agency has approved 65 biosimilar products for various health conditions.
Merilog — like Novolog — should be administered 5 to 10 minutes before the start of a meal, according to the release. It can cause side effects such as:
- severe allergic reactions;
- hypokalemia;
- hypoglycemia;
- injection site reactions;
- swelling of hands and feet; and
- weight gain.
“The FDA has now approved three biosimilar insulin products to treat diabetes,” Peter Stein, MD, director of the office of new drugs in the FDA’s Center for Drug Evaluation and Research, said in the release. “Today’s approval highlights our continued efforts to improve the efficiency of the biosimilar approval process to help support a competitive marketplace and increase options for costly treatments, like insulin.”
Perspective
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On Feb. 14, the FDA approved the first biosimilar insulin aspart by the name of Merilog. The hope is that this rapid-acting analog to be used for mealtime insulin with multiple injections or insulin pump therapy would further increase access to insulin treatment options with lower costs.
While many applaud this addition to the U.S. formulary, the situation is more complex than it was a few years ago. While expensive, retail prices today are lower than in the past. Furthermore, there are insulin caps in 25 states for commercial insurance, according to the American Diabetes Association, in addition to a $35 monthly cap for Medicare patients. Furthermore, each insulin company has programs to assist those patients in need with affordable insulin.
When Semglee (insulin glargine-yfgn, Biocon/Mylan) was approved in July of 2021, it was noted that this would be the first glargine biosimilar that was interchangeable with Lantus (Sanofi) and, according to Dr. Janet Woodcock of the FDA “would have the potential to greatly reduce health care costs.” (For more information on this, visit https://www.medicare.gov/about-us/prescription-drug-law). But the insulin caps changed all of that, and in fact, when looking at GoodRx.com today for Bellevue, Washington, the lowest price for Semglee is $27.77 while for Lantus it is $35 for a box of five pens. At least in this community, we would all agree that insulin is affordable, especially compared with 10 years ago.
Let’s look at the rapid-acting analog. Humalog (Eli Lilly) at GoodRx.com costs $166 for a box of five pens. However, Eli Lilly makes a generic Humalog which costs as low as $8.65. Admelog (Sanofi), a biosimilar insulin lispro which was approved in December 2017, today costs $197. For a patient with no insurance coverage, the biosimilar lispro costs more than the reference Humalog.
Does that mean we shouldn’t be thankful for the introduction of Merilog? Absolutely not. Consider the two companies that together make the majority of the insulin in the world, Eli Lilly and Novo Nordisk, also manufacture the majority of the world’s GLP-1s. These drugs to date are so popular around the world, there are shortages despite the incredible expense. This cost makes them more profitable than insulin. If you were a CEO or stockholder of one of these companies, and you had manufacturing space to make a drug, which drug would you choose? Especially given the numbers of people who could benefit from the GLP-1s compared with insulin.
My thought is the more companies making insulin, the better. While I hope in 10 or 20 years, both Eli Lilly and Novo Nordisk are still making insulin, if they transition to drugs with higher profits, we shouldn’t be surprised. This is the reason why I was delighted to see Sanofi develop biosimilar insulin aspart, and my hope is Mylan Pharmaceuticals and Biocon Biologics continue to manufacture Semglee.
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