The U.S. Food and Drug Administration (FDA) has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for improving glycemic control in adults and children with diabetes mellitus.

This milestone marks the first rapid-acting insulin biosimilar approved by the FDA, expanding treatment options for millions of Americans managing diabetes.

Merilog will be available in two forms:

• 3 mL prefilled pen (for single-patient use)

• 10 mL multiple-dose vial

This approval makes Merilog the third insulin biosimilar approved in the U.S., following two long-acting biosimilars authorized in 2021.

The introduction of biosimilars aims to increase accessibility to essential medications by fostering competition and potentially reducing costs.

Read: Types of Insulins

Why This Approval Matters

According to the FDA’s Center for Drug Evaluation and Research, the agency remains committed to expanding access to insulin by streamlining the approval process for biosimilars. Dr. Peter Stein, the office’s director, stated:

“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.”

Diabetes affects over 38 million people in the U.S., with approximately 8.4 million relying on insulin therapy for daily blood sugar management. Despite its necessity, insulin remains costly, making biosimilar options like Merilog a potentially more affordable alternative for patients.

Understanding Merilog and Its Benefits

Like Novolog, Merilog is a rapid-acting insulin analog designed to lower blood sugar spikes during meals. It should be taken 5 to 10 minutes before eating and is administered via subcutaneous injection in the stomach, thighs, upper arms, or buttocks.

Merilog offers the same safety and effectiveness as Novolog, ensuring patients receive consistent diabetes management at a potentially lower cost.

Comparison: Merilog vs. Novolog

Potential Side Effects

While Merilog is safe and effective, it may cause serious side effects, including:

• Hypoglycemia (low blood sugar)

• Severe allergic reactions

• Hypokalemia (low potassium levels)

Other common side effects include:

• Injection site reactions (redness, swelling, itching)

• Rash

• Lipodystrophy (skin thickening or pitting at the injection site)

• Weight gain

Final Thoughts

The FDA’s approval of Merilog is a significant step toward expanding diabetes treatment options. With its biosimilar designation, Merilog ensures comparable efficacy and safety to Novolog while fostering greater accessibility to insulin therapy.

As biosimilar products continue to emerge, patients may benefit from more affordable insulin options, potentially reducing the financial burden of diabetes management.