忘记密码?

您还可以用以下方式直接登录:

健康新闻

󰀂在线客服

客服热线:400-0596-618

您所在的位置:主页 > 经典案例 > 正文

FDA接受审查诺华生物仿制药Zarzio

发布日期:2014-07-26 15:21来源:生物谷作者:佚名点击量:

FDA接受审查诺华生物仿制药Zarzio,该药为安进品牌药Neupogen(非格司亭)的生物仿制药。在美国以外地区,Zarzio已成为排名第一的非格司亭仿制药,欧洲市场份额达30%。

FDA接受审查诺华生物仿制药Zarzio

2014年7月26日讯 /生物谷BIOON/ --诺华(Novartis)仿制药单元山德士(Sandoz)7月24日宣布,FDA已接受filgrastim(非格司亭)生物制剂许可申请(BLA),该药为安进(Amgen)品牌药Neupogen的生物仿制药,用于正在接受骨髓抑制性抗癌药物治疗且伴有严重中性粒细胞减少症(neutropenia)的非骨髓恶性肿瘤患者,以减少严重中性粒细胞减少症的持续时间,降低感染的发生率。在美国,诺华是首个提交生物仿制药的公司,Neupogen在2013年的销售额为14亿美元。

filgrastim BLA是根据美国《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。在美国以外地区,山德士filgrastim已经以品牌名Zarzio在40多个国家销售。在全球范围内,Zarzio已成为排名第一的非格司亭生物仿制药,在欧洲的市场份额达30%。

目前,山德士在全球生物仿制药市场份额超过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等品牌生物药的仿制药,这些品牌药的年销售额超过百亿美元。

同时,得益于不断变化的法规和迫在眉睫的生物技术专利悬崖,全球生物仿制药有望蓬勃发展。根据联合市场调研(AMR)近日发布的一份新报告,随着重磅生物药如修美乐(Humira,通用名:adalimumab,阿达木单抗)和类克(Remicade,通用名:infliximab,英夫利昔单抗)失去专利保护,全球生物仿制药市场将在2020年达到350亿美元,而该市场在2013年仅为13亿美元。

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:FDA accepts Sandoz application for biosimilar filgrastim

Sandoz is the first company to announce it has filed for approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

FDA's acceptance of Sandoz's filing is an important first step in increasing US patient access to affordable, high-quality biologics

Sandoz is a global leader in biosimilars with over 50% share of the global biosimilars market [1]

Holzkirchen, July 24, 2014 - Sandoz, a Novartis Group company, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

The reference product - Amgen's NEUPOGEN® - is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.

"This filing acceptance represents a significant step toward making high-quality biologics more accessible in the US and we applaud FDA for its progress in making this a reality," said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. "As they've done in Europe and other highly-regulated markets around the world, biosimilars are poised to increase US patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall healthcare system."

Under the brand name ZARZIO®, the Sandoz biosimilar filgrastim has been marketed in more than 40 countries outside the US, generating nearly six million patient-exposure days of experience. ZARZIO is the number one biosimilar filgrastim globally and is the leading daily G-CSF in Europe with 30 percent volume market share.

Sandoz is a pioneer in biosimilars and the global market leader with over 50% share of all biosimilars approved in the highly-regulated markets of Canada, Europe, Japan and Australia. Sandoz currently markets three biosimilars outside the US; each of which occupies the #1 biosimilar position in its respective category. Sandoz biosimilars are sold in over 60 countries and have generated over 200 million patient-exposure days in experience. Sandoz also has an unrivalled pipeline with several molecules in various stages of development. Sandoz now has six molecules in Phase III clinical trials/filing preparation, more than any other company in the industry.

[1] Includes products approved in North America, Europe, Japan and Australia

关注健康新闻网:http://news.wenbing.cn/