美国食品和药物管理局批准了阿科德生物制药公司的IMULDOSA, FDA approves Accord BioPharma's IMULDOSA, a biosimilar for chronic inflammatory conditions.
FDA 已批准 IMULDOSA （ustekinumab-srlf），一种与 STELARA （ustekinumab） 类似的生物仿制药，用于治疗银屑病、银屑病关节炎、克罗恩病和溃疡性结肠炎等慢性炎症性疾病。 The FDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar to STELARA (ustekinumab), for treating chronic inflammatory conditions like psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. 伊穆尔多萨由Intas药品的子公司Accord BioPharma制造, 预计将于2025年初推出. Manufactured by Accord BioPharma, a subsidiary of Intas Pharmaceuticals, IMULDOSA is set for launch in early 2025. 这项批准标志着《协定》继HERCESSI之后的第二个生物类同,进一步扩大了它在美国市场的存在。 This approval marks Accord's second biosimilar following HERCESSI, further expanding its presence in the U.S. market.