近日，诺华（Novartis）旗下仿制药单元山德士（Sandoz）开发的一款仿制药Glatopa近喜获FDA批准，该药是梯瓦（Teva）品牌药Copaxone（醋酸格拉替雷注射剂，20mg/ml）的仿制药。Glatopa也是FDA批准的首个Copaxone仿制药，作为每日一次的注射药物，用于复发型多发性硬化症（RMS）的治疗。

批准日期：2015年4月17日  公司：山德士

GLATOPA（醋酸格拉替雷 glatiramer acetate）注射液，用于皮下使用

美国最初批准：1996年

最近的重大变化

警告和注意事项，注射后反应：1/2018

作用机制

醋酸格拉替雷在MS患者中发挥作用的机制尚不完全清楚。然而，醋酸格拉替雷被认为通过改变被认为是MS发病机理的免疫过程起作用。这一假设得到了研究的发现的支持，这些研究已被用于探索实验性自身免疫性脑脊髓炎的发病机理，这是一种通过免疫中枢神经系统衍生的含有髓鞘的材料在动物中诱导的病症，并且通常用作MS的实验动物模型。在动物和体外系统中的研究表明，在其给药时，醋酸格拉替雷特异性抑制性T细胞在外周被诱导和活化。

因为醋酸格拉替雷可以改变免疫功能，所以存在关于其改变天然存在的免疫应答的潜力的担忧。没有证据表明醋酸格拉替雷可以做到这一点，但尚未对此进行系统评估[见警告和注意事项]。

适应症和用法

Glatopa适用于治疗复发型多发性硬化症患者。

剂量和给药

•仅适用于皮下注射;剂量不可互换

•Glatopa每天20mg/mL

•Glatopa 40mg/mL，每周三次

•使用前，让溶液温热至室温

剂量形式和强度

•注射：20mg/mL，单剂量预充式注射器，白色柱塞

•注射：40mg/mL，单剂量预充式注射器，蓝色柱塞

禁忌症

已知对醋酸格拉替雷或甘露醇的超敏反应

警告和注意事项

•注射后反应（潮红，胸痛，心悸，心动过速，焦虑，呼吸困难，咽喉收缩和/或荨麻疹），通常是短暂的和自我限制的

•胸痛，通常是短暂的

•可能发生脂肪萎缩和皮肤坏死。指导患者采用适当的注射技术并旋转注射部位

•Glatopa可以改变免疫反应

不良反应

•在醋酸格拉替雷注射液20mg/mL的对照研究中，最常见的不良反应（≥10％，≥安慰剂≥1.5倍）为：注射部位反应，血管扩张，皮疹，呼吸困难和胸痛。

•在醋酸格拉替雷注射液40mg/mL的对照研究中，最常见的不良反应（≥10％，≥安慰剂≥1.5倍）为：注射部位反应。

要报告疑似不良反应，请致电1-800-525-8747联系Sandoz Inc.或致电1-800-FDA-1088或www.fda.gov/medwatch联系FDA

用于特定人群

•哺乳母亲：目前尚不清楚醋酸格拉替雷注射液是否会在​​人乳中排出体外

•儿科用途：18岁以下患者尚未确定Glatopa的安全性和有效性

如何提供/存储和处理

Glatopa（醋酸格拉替雷注射液）是1mL单剂量玻璃注射器中的透明，无色至微黄色无菌无热原溶液，注射器长度为1/2英寸，29号针头提供：

•含有白色柱塞的单剂量预充式注射器每毫升20毫克，采用30个计数纸盒提供的单个泡罩包装（NDC 0781-3234-34）

•含有蓝色柱塞的单剂量预充式注射器中每毫升40毫克，采用12计数纸盒提供的单个泡罩包装（NDC 0781-3250-89）

将Glatopa冷冻保存在2°C至8°C（36°F至46°F）。 如果需要，患者可以将Glatopa在室温，15°C至30°C（59°F至86°F）下储存长达一个月，但最好是冷藏。 避免暴露在较高温度或强光下。 不要冻结Glatopa。 如果Glatopa注射器冻结，应将其丢弃。

完整说明书附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5f01e40a-b6f6-40fb-b37c-3d06f1428e86

Sandoz announces US FDA approval and launch of Glatopa® 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis

Glatopa® 40 mg/mL is a fully substitutable, AP-rated generic version of Copaxone®* (glatiramer acetate injection) 40 mg/mL

Glatopa 40 mg/mL, along with Glatopa® 20 mg/mL, which was launched in the US in June 2015, will offer patients a complete range of dosing options

A full range of patient support services for Glatopa® is available through GlatopaCare®

HOLZKIRCHEN, Germany, Feb. 13, 2018 /PRNewswire/ -- Sandoz, a Novartis division, today announced the US FDA approval and launch of Glatopa® (glatiramer acetate injection) 40 mg/mL.

Glatopa (glatiramer acetate injection) 40 mg/mL is FDA-approved as a fully-substitutable, AP-rated generic version of Copaxone®* (glatiramer acetate injection) 40 mg/mL three times-a-week therapy for relapsing forms of multiple sclerosis (MS). Glatopa was developed under a collaboration agreement between Momenta Pharmaceuticals, Inc. and Sandoz and is produced in the US.

"The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products. We look forward to bringing this product to patients and healthcare professionals and providing a full range of patient support services for Glatopa through GlatopaCare®," said Richard Francis, CEO, Sandoz.

Glatopa 40 mg/mL is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Glatopa 40 mg/mL, along with Glatopa 20 mg/mL, will offer patients a complete range of dosing options. Glatopa 20 mg/mL was made available in the US in June 2015. Patients can expect the same patient services for Glatopa 40 mg/mL as for Glatopa 20 mg/mL.

Sandoz GlatopaCare will offer a $0 co-pay support program to qualified patients. To help increase patient confidence with administering injections, patients will receive personalized injection training, 24-hour access to nurses for Glatopa®-related questions and a free Starter Kit, which includes the Glatopaject® injection device, designed to work with both Glatopa 20 mg/mL and 40 mg/mL prefilled syringes.

Glatopa® Indication and Important Safety Information

Indication

Glatopa® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing-forms of multiple sclerosis.

Important Safety Information 

Glatopa® is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

Approximately 16% of glatiramer acetate injection 20mg/mL patients vs. 4% of those on placebo, and approximately 2% of glatiramer acetate injection 40mg/mL patients vs. none on placebo experienced a constellation of symptoms that may occur within minutes after injection and included at least 2 of the following: flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and urticaria. These symptoms generally have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.

Transient chest pain was noted in 13% of glatiramer acetate injection 20mg/mL patients vs. 6% of placebo patients, and approximately 2% of glatiramer acetate injection 40mg/mL patients vs. 1% on placebo. While some episodes of chest pain occurred in the context of the immediate post-injection reaction described above, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain was transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than 1 such episode, and episodes usually began at least 1 month after the initiation of treatment.