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BioDrugs. 2019 Feb;33(1):117-120. doi: 10.1007/s40259-019-00334-9.
Pegfilgrastim-jmdb/MYL-1401H (FULPHILA™) [hereafter referred to as pegfilgrastim-jmdb] is a biosimilar of the reference pegylated recombinant granulocyte colony-stimulating factor pegfilgrastim. It is approved for use in patients receiving chemotherapy for malignancy to decrease the incidence of infection, as manifested by febrile neutropenia, in the USA and to reduce the duration of neutropenia and the incidence of febrile neutropenia in the EU. Pegfilgrastim-jmdb has similar physicochemical characteristics and functional properties to those of US- and EU-sourced reference pegfilgrastim, and the pharmacodynamic and pharmacokinetic similarity of the agents has also been demonstrated in healthy volunteers. Pegfilgrastim-jmdb demonstrated clinical efficacy equivalent to that of EU-sourced reference pegfilgrastim in patients with newly diagnosed Stage II/III breast cancer receiving neoadjuvant or adjuvant chemotherapy and was generally well tolerated in this patient population. The overall safety profile and immunogenic potential of the two agents was similar. The role of reference pegfilgrastim in the management of chemotherapy-induced neutropenia is well established and pegfilgrastim-jmdb provides an effective biosimilar alternative for patients requiring pegfilgrastim therapy.
培格非格司亭-jmdb/ MYL-1401H（复菲乐）[后文简称培格非格司亭-jmdb]是参照聚乙二醇化重组粒细胞集落刺激因子培格非格司亭的生物类似药。该药已获批准在美国用于接受化疗的恶性肿瘤患者，以降低发热性中性粒细胞减少症的感染发生率，在欧盟则用于降低中性粒细胞减少症的持续时间和发热性中性粒细胞减少症的发生率。培格非格司亭-jmdb与源自美国和欧盟的参照培格非格司亭具有相似的理化特征和功能特性，且这两种药物在健康志愿者中的药效学和药代动力学相似性也已得到证实。在接受新诊断的 II/III 期乳腺癌新辅助或辅助化疗的患者中，培格非格司亭-jmdb的临床疗效与源自欧盟的参照培格非格司亭相当，且在该患者人群中总体耐受性良好。两种药物的安全性概况和免疫原性潜力相似。参照培格非格司亭在化疗引起的中性粒细胞减少症的治疗中的作用已得到充分确立，培格非格司亭-jmdb为需要培格非格司亭治疗的患者提供了有效的生物类似药替代选择。
