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FDA OKs First Rapid-Acting Insulin Biosimilar for Diabetes

The U.S. Food and Drug Administration approved Merilog as a biosimilar to Novolog for improving glycemic control in diabetes patients.
Merilog is the first rapid-acting insulin biosimilar approved by the FDA, available in a prefilled pen and a multi-dose vial.
Approval of Merilog was granted to Sanofi-Aventis U.S. LLC, marking it as the third insulin biosimilar approved by the FDA.
The FDA emphasizes that biosimilar options like Merilog can increase access to affordable diabetes medications for the millions of insulin users in the U.S.

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MedPage Today

FDA OKs First Rapid-Acting Insulin Biosimilar for Diabetes

(MedPage Today) -- The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and children

8 days ago·New York, United States

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hartfordcitynewstimes.com

+23 Reposted by 23 other sources

FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes

Agency Continues Efforts to Increase Access to Insulin Treatment Options

8 days ago·Hartford City, United States

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biopatrika.com

FDA Approves First Rapid-Acting Insulin Biosimilar, Merilog - BioPatrika

February 16, 2025 | BioPatrika News Desk In a significant advancement for diabetes care, the U.S. Food and Drug Administration (FDA) has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart), marking the first-ever approval of a rapid-acting insulin biosimilar. The approval is expected to enhance accessibility and affordability of insulin for millions of […] The post FDA Approves First Rapid-Acting Insulin Biosimilar…

7 days ago

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pipelinereview

FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes - Pipelinereview

Agency Continues Efforts to Increase Access to Insulin Treatment Options SILVER SPRING, MD, USA I February 14, 2025 I Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved …

7 days ago

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Pharmacy Times

Rapid-Acting Insulin Biosimilar Receives FDA Approval for Diabetes

Insulin-aspart-szjj (Merilog) is the first rapid-acting insulin biosimilar product approved by the FDA.

8 days ago

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healtheconomics.com

FDA Approves Merilog: First Rapid-Acting Insulin Biosimilar for Diabetes

The U.S. Food and Drug Administration has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), marking it as the first rapid-acting insulin biosimilar for diabetes treatment. Merilog is designed to help manage blood sugar spikes during meals for both adults and children with diabetes. This new approval aims to increase patient access to affordable insulin by providing a competitive treatment option. Merilog is availa…

8 days ago

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