Exploring the Benefits of Rapid-Acting Insulin Biosimilars
Significant developments have emerged in the field of diabetes management. The FDA has granted approval for the first rapid-acting insulin biosimilar, representing a substantial leap forward in diabetes treatment.
Merilog (insulin-aspart-szjj), a biosimilar to Novolog, has been approved for enhancing glycemic control in both adult and pediatric patients diagnosed with diabetes mellitus. This approval signifies the introduction of the first rapid-acting insulin biosimilar in the United States, with the objective of improving patient access to effective insulin therapies.
Key Highlights:
- Merilog stands as the inaugural rapid-acting insulin biosimilar sanctioned by the FDA, providing enhanced glycemic control for diabetes patients of all ages.
- This approval is the third instance of insulin biosimilar authorization by the FDA, following the approval of two long-acting insulin biosimilars in 2021.
- The endorsement of Merilog aligns with the FDA’s ongoing initiatives to broaden access to safe, effective, and affordable insulin alternatives.
Merilog is classified as a rapid-acting human insulin analog and is the first of its kind to receive FDA approval. Administering Merilog subcutaneously five to ten minutes prior to meals is designed to improve glycemic control in individuals with diabetes. The approval encompasses both a 3-mL single-patient-use prefilled pen and a 10-mL multiple-dose vial.
Notable serious side effects associated with Merilog include hypoglycemia, severe allergic reactions, and decreased potassium levels in the bloodstream. Common side effects may consist of reactions at the injection site, itching, rashes, skin thickening or pitting at the injection site, weight gain, and swelling in the hands and feet.
