美国食品和药物管理局批准首个可互换生物类似物OMLYCLO用于喘,鼻,食物过敏和疹. FDA approves first interchangeable biosimilar OMLYCLO for asthma, nasal polyps, food allergy, and hives.

美国食品和药物管理局批准了一种新型的300mg/2mL单剂量预填注射器形式的OMLYCLO (奥马利祖马布-伊杰克),这是XOLAIR®的生物类似药,使其成为该类中的第一个可互换的生物类似药. The FDA has approved a new 300mg/2mL single-dose prefilled syringe form of OMLYCLO (omalizumab-igec), a biosimilar to XOLAIR®, making it the first interchangeable biosimilar in its class. 该药物已获批准用于治疗喘,长期鼻炎与鼻,食物过敏和慢性疹,由Celltrion USA销售,并具有过敏反应的风险. Approved for treating asthma, chronic rhinosinusitis with nasal polyps, food allergy, and chronic urticaria, the drug is marketed by Celltrion USA and carries a risk of anaphylaxis. 在2024年5月欧洲联盟批准后,这一扩大增加了先前核准的配方。 This expansion adds to previously approved formulations and follows its May 2024 approval in the European Union.