2014年12月9日讯 /生物谷BIOON/ --2014年第56届美国血液学会年会（ASH）于12月6日-9日在美国旧金山举行。近日，诺华（Novartis）在会上公布了非格司亭（filgrastim）生物仿制药III期临床（PIONEER）数据。该研究证明，诺华开发的filgrastim生物仿制药用于正接受骨髓抑制性新辅助化疗的乳腺癌患者预防严重中性粒细胞减少症（neutropenia）时疗效媲美安进品牌药优保津(Neupogen)。此外，研究还表明，患者在每个治疗周期中filgrastim仿制药和Neupogen反复切换，对治疗效果、安全性或免疫原性无任何影响。
PIONEER是一项III期研究，在218例正接受骨髓抑制性新辅助化疗的乳腺癌患者中开展，旨在比较实验性filgrastim仿制药与参考品牌药Neupogen的疗效和安全性。该研究的数据将用于支持filgrastim生物仿制药在美国的监管批准。
山德士（Sandoz）全球生物制药及肿瘤注射剂负责人Mark McCamish博士指出，对这些临床研究数据感到满意，这些数据证实了我们所开发的filgrastim生物仿制药在疗效和安全性方面媲美品牌药Neupogen。
今年7月，FDA接受审查诺华旗下仿制药单元山德士（Sandoz）提交的filgrastim生物制品许可申请（BLA），使诺华成为通过美国《生物制剂的价格竞争和创新法案》（BPCIA）所创立的新生物仿制药途径提交生物仿制药的首家药企。山德士已在美国以外的市场推出了3种生物仿制药，每一种产品均为对应品牌药的首个上市仿制药，产品已在全球60多个国家销售。在全球范围内，filgrastim生物仿制药Zarzio已成为排名第一的filgrastim生物仿制药并在40多个国家销售，欧洲市场份额达30%。
目前，诺华旗下仿制药公司山德士已成为全球排名第一的生物仿制药公司，市场份额超过50%，该公司的目标是保持其全球生物仿制药市场的领导者地位，其后期管线产品还包括Humira、Enbrel、Rituxan、Procrit等6个品牌生物药的仿制药，比生物仿制药领域任何其他公司要多，这些品牌药的年销售额高达数百亿美元。
关于Neupogen（filgrastim）：
Neupogen（通用名：filgrastim，非格司亭）是安进应用重组DNA技术生产的甲硫氨酸人粒细胞集落刺激因子(Granulocyte colony-stimulating factor，G-CSF)，可促进造血辅助细胞增殖分化，明显增加外周血中性粒细胞数，并有增强粒细胞的功能，如对成熟的中性粒细胞可增强其吞噬活性和抗体依赖性细胞介导的细胞毒作用。
Neupogen适用于：(1)促进骨髓移植后中性粒细胞的恢复；(2)治疗肿瘤化疗后中性粒细胞减少症；(3)治疗伴随骨髓异常增生综合征之中性粒细胞减少症；(4)治疗伴随再生不良性贫血之中性粒细胞减少；(5)治疗先天性、特发性中性粒细胞减少症。
英文原文：Novartis copy of Amgen biotech drug shows similar efficacy-study
ZURICH (Reuters) - Novartis said its copycat version of Amgen's Neupogen for patients with low white blood cell counts works as well as the original drug in a late-stage trial.
The medicine, made by Novartis' generics arm Sandoz, was being tested in patients with breast cancer undergoing chemotherapy, which often knocks out their white blood cells, giving rise to a condition known as neutropenia.
Results of the Phase III study also showed switching at each cycle between the original drug, also known as filgrastim, and the experimental copy had no impact on efficacy and safety, Novartis said on Monday.
The data will be used to support Sandoz' application for approval of a copycat filgrastim, which was accepted by U.S. regulators at the end of July under a new pathway for so-called biosimilar drugs.
Sandoz is the world leader in cheaper copies of biotech medicines known as biosimilars, which are expected to account for approximately one quarter of the $100 billion worth of sales stemming from off-patent biological drugs by the end of the decade.
The generics company already sells a biosimilar version of Amgen's drug in more than 40 other countries, but the United States has been slower than other markets to establish a regulatory framework for biosimilars.
Sandoz currently sells three biosimilars outside the United States and has a further six molecules in late-stage development.