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美国食品药品监督管理局批准GLP-1仿制药

FDA approves GLP-1 generic

Becker's Hospital Review 等信源发布 2024-12-24 05:46

可切换为仅中文


On Dec. 23, the FDA approved Hikma Pharmaceuticals' liraglutide injection, a generic version of Novo Nordisk's Victoza. The FDA first approved Victoza in 2010 for Type 2 diabetes, later expanding its use in 2019 as a pediatric, injectable treatment for patients 10 or older. Hikma's generic includes similar warnings to the brand-name drug, such as risks of thyroid C-cell tumors, pancreatitis, hypoglycemia, kidney failure and acute gallbladder disease. The injectable GLP-1 is indicated to improve glycemic control in patients 10 and older.

12月23日,FDA批准了Hikma Pharmaceuticals的利拉鲁肽注射液,这是诺和诺德Victoza的仿制药。FDA于2010年首次批准Victoza治疗2型糖尿病,随后于2019年扩大其作为10岁或以上患者的儿科注射治疗。Hikma的仿制药包括与该品牌药物类似的警告,例如甲状腺C细胞肿瘤,胰腺炎,低血糖,肾衰竭和急性胆囊疾病的风险。注射用GLP-1可改善10岁及以上患者的血糖控制。

This marks the second GLP-1 medicine with a generic option. In November, the FDA approved a generic for Byetta (exenatide), another diabetes therapy. A few other drugmakers are preparing to enter the GLP-1 market, which remains dominated by Eli Lilly and Novo Nordisk. In June, Teva Pharmaceuticals launched its generic version of Victoza.

这标志着第二种GLP-1药物具有通用选项。11月,FDA批准了另一种糖尿病治疗药物Byetta(艾塞那肽)的仿制药。其他一些制药商正准备进入GLP-1市场,该市场仍由礼来和诺和诺德占据主导地位。6月,Teva Pharmaceuticals推出了仿制药Victoza。

Sandoz plans to release a generic for Ozempic (semaglutide) when the market opens in 2030. .