FDA Approves Merilog (insulin-aspart-szjj), a Biosimilar to NovoLog

FDA批准了Merilog（门冬胰岛素-szjj），这是NovoLog的一种生物类似药。

February 14, 2025 --

2025年2月14日 --

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 by the FDA.

今天，美国食品和药物管理局批准了Merilog（门冬胰岛素-szjj）作为NovoLog（门冬胰岛素）的生物类似药，用于改善成年和儿童糖尿病患者的血糖控制。Merilog是一种速效人胰岛素类似物，是FDA批准的首个速效胰岛素生物类似药产品。

As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial..

作为一种速效胰岛素，Merilog有助于降低糖尿病患者餐后血糖峰值，从而改善血糖控制。此次批准涵盖了3毫升（mL）单人使用预填充笔和10毫升（mL）多剂量瓶两种形式。

Merilog is the third insulin biosimilar product approved by the FDA and joins the two long-acting insulin biosimilar products approved in 2021 by the FDA. Approval of biosimilar products can increase patient access to safe and effective treatment options.

Merilog 是 FDA 批准的第三种胰岛素生物类似药，与2021年FDA批准的两种长效胰岛素生物类似药一同加入市场。生物类似药的批准可以增加患者获得安全有效治疗选择的机会。

'The FDA has now approved three biosimilar insulin products to treat diabetes,” said Peter Stein, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “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.

“FDA现已批准三种用于治疗糖尿病的生物类似胰岛素产品，”FDA药物评估与研究中心新药办公室主任彼得·斯坦因医学博士说，“今天的批准彰显了我们持续改进生物类似药审批流程效率的努力，以支持竞争性市场，并为像胰岛素这样昂贵的治疗增加选择。”

Increasing access to safe, effective and high-quality medications at potentially lower cost remains a continued priority for the FDA.'.

以可能更低的成本增加安全、有效和高质量药物的获取渠道仍然是FDA的持续优先事项。

Biological products include medications for treating many serious illnesses and chronic health conditions, including diabetes. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product).

生物制品包括用于治疗许多严重疾病和慢性健康状况的药物，包括糖尿病。生物类似药是一种与已获FDA批准的生物制品（也称为参照产品）高度相似且无临床意义差异的生物制品。

Patients can expect the same safety and effectiveness from the biosimilar as from the reference product. To date, the FDA has approved 65 biosimilar products for a variety of health conditions..

患者可以预期生物类似药与参照产品具有相同的安全性和有效性。迄今为止，FDA已经批准了65种生物类似药产品用于各种健康状况。

More than 38 million people in the U.S. have been diagnosed with diabetes, a disease that occurs when blood glucose (sugar) is too high. Approximately 8.4 million Americans rely on insulin therapy, either rapid-acting and/or long-acting, to manage diabetes. Insulin, a hormone made by the pancreas, helps glucose get into a person’s cells to be used for energy.

美国已有超过3800万人被诊断出患有糖尿病，这是一种血糖（糖分）过高的疾病。大约840万美国人依靠胰岛素治疗（速效和/或长效）来管理糖尿病。胰岛素是由胰腺分泌的一种激素，有助于葡萄糖进入人体细胞以提供能量。

With diabetes, the pancreas doesn’t make enough insulin to keep blood sugar levels in the normal range, which can lead to serious health problems for patients..

糖尿病患者胰腺分泌的胰岛素不足，无法使血糖水平保持在正常范围内，这会给患者带来严重的健康问题。

'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 life-saving medications,' said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research..

“对于数百万依赖每日胰岛素注射治疗糖尿病的患者来说，拥有快速作用胰岛素注射的生物类似药选择确实可以带来改变，因为生物类似药有潜力增加这些救命药物的可及性，” FDA 药物评估与研究中心治疗性生物制品和生物类似药办公室主任 Sarah Yim 医学博士表示。

Like NovoLog, Merilog should be administered within five to ten minutes prior to the start of a meal. Merilog is administered subcutaneously (under the skin) by injection into the stomach, buttocks, thighs or upper arms. Dosing of Merilog should be individualized and adjusted based on the patient’s needs..

像诺和锐一样，Merilog应在餐前五到十分钟内给药。Merilog通过皮下注射（皮肤下）到腹部、臀部、大腿或上臂进行给药。Merilog的剂量应根据患者的需求进行个性化调整。

Merilog may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions and hypokalemia (low potassium in blood). Other common side effects may include injection site reactions, itching, rash, lipodystrophy (skin thickening or pitting at the injection site), weight gain and swelling of hands and feet..

Merilog 可能导致严重的副作用，包括低血糖（血糖过低）、严重过敏反应和低钾血症（血液中钾含量过低）。其他常见的副作用可能包括注射部位反应、瘙痒、皮疹、脂肪营养不良（注射部位皮肤增厚或凹陷）、体重增加以及手足肿胀。

The FDA granted approval of Merilog to Sanofi-Aventis U.S. LLC.

FDA批准了Merilog给赛诺菲-安万特美国有限责任公司。

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products..

美国食品药品监督管理局（FDA）是美国卫生与公众服务部下属的一个机构，通过确保人用和兽用药品、疫苗及其他生物制品、医疗器械的安全性、有效性和可靠性来保护公众健康。该机构还负责保障我国食品供应、化妆品、膳食补充剂、辐射发射电子产品以及烟草产品的安全性。

Source: FDA

来源：FDA

Merilog (insulin aspart-szjj) FDA Approval History

Merilog（门冬胰岛素-szjj）FDA审批历史

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