DelveInsight的 “ 菲格拉斯汀 –生物仿制药洞察，2020年，” report provides comprehensive insights about 20+ companies and 20+ marketed and pipeline drugs in 菲格拉斯汀 Biosimilars landscape. It covers the marketed and pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
菲格拉斯汀：概述
菲格拉斯汀, sold under the brand name Neupogen among others, is a medication used to treat low neutrophil count. Low neutrophil counts may occur with HIV/AIDS, following chemotherapy or radiation poisoning, or be of an unknown cause. It is marketed as the brand name Neupogen by Amgen (initially approved in 1998). 菲格拉斯汀 is a growth factor that stimulates the production, maturation, and activation of neutrophils (a type of white blood cell). 菲格拉斯汀 also stimulates the release of neutrophils from the bone marrow. In patients receiving chemotherapy, filgrastim can accelerate the recovery of neutrophils, reducing the neutropenic phase (the time in which people are susceptible to infections).
This segment of the 菲格拉斯汀 report encloses its detailed analysis of various drugs in different stages of clinical development, including marketed, phase III, II, I and preclinical. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Nivestym is a leukocyte growth factor that primarily stimulates neutrophils. The 脑脊液 receptor through which Nivestym acts has also been found on tumor cell lines. The possibility that Nivestym acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established. Nivestym is used to treat neutropenia, a lack of certain white blood cells caused by cancer, bone marrow transplant, receiving chemotherapy, or by other conditions. Nivestym may also be used for purposes not listed in this medication guide. In July 2018, 辉瑞 announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product.
格拉斯托菲尔 is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of 格拉斯托菲尔 are similar in adults and children receiving cytotoxic chemotherapy. 格拉斯托菲尔 is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). The active substance in 格拉斯托菲尔, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). 菲格拉斯汀 acts in the same way as naturally produced 脑脊液 by encouraging the bone marrow to produce more white blood cells.
报告中提供了更多产品详细信息。
Tanvex Biopharma is developing 菲格拉斯汀 biosimilar labeled as TX-01 for the treatment of Neutropenia. The mechanism of action of the drug is that it acts as Haematopoietic cell growth factor stimulants. In 2019, Tanvex BioPharma receives complete response letter from the US FDA for filgrastim biosimilar (TX 01) in Neutropenia.
格兰仕 is Mycenax’s filgrastim, the biosimilar version of Neupogen, and the recombinant human granulocyte colony-stimulating factor, 脑脊液. It can stimulate the growth of the white cell. The development of 格兰仕 followed the regulatory pathway of the biosimilar, with high biosimilarity to its reference product, and complied with the requirements of the European Medicine Agency. This project is granted by the Ministry of Economic Affairs (MOEA) and selected as the critical path project by the Center for Drug Evaluation (CDE) in Taiwan. Mycenax has completed 格兰仕’s pre-clinical development and will focus on the application of the new delivery system or new formulation for patient’s ease of using 格兰仕.
报告中提供了更多产品详细信息。
报告的此部分提供有关基于定义报告范围的以下参数而分离的不同Filgrastim生物仿制药的见解，例如：
有大约。 20多家正在为Filgrastim开发疗法的主要公司。
DelveInsight的报告涵盖了临床开发不同阶段的大约20多种产品，例如
菲格拉斯汀管道报告提供了《管理途径》对管道药物的治疗性评估。产品已根据各种ROA进行了分类，例如
产品已分类为多种分子类型，例如
药物已分类为各种产品类型，例如Mono，Combination和Mono / Combination。
该报告提供了对上市，III，II，I和临床前阶段的不同治疗候选药物的见解。它还分析了参与开发关键药物的非格拉斯汀生物仿制药的主要参与者。
该报告涵盖了合作，收购和合并，许可的详细信息，以及对新兴的Filgrastim生物仿制药的全面治疗评估。
当前的治疗方案和新兴疗法：
1.关键见解
2. 菲格拉斯汀生物仿制药：快照
3.执行摘要
3.1。总览
3.2。生物制品学的基础知识。
3.3。生物仿制药与仿制药不同
3.4。生物仿制药经济学–降低价格的承诺，但付出了什么代价？
3.5。患者需要了解哪些有关生物仿制药的信息
4.生物仿制药的监管展望
4.1。北美
4.1.1。我们
4.1.2。加拿大
4.2。欧洲
4.3。亚太地区
4.3.1。中国
4.3.2。印度
4.3.3。日本
4.3.4。南韩
4.3.5。澳大利亚
4.4。世界其他地区
4.4.1。巴西
4.4.2。墨西哥
4.4.3。阿根廷
4.4.4。沙特阿拉伯
*更多国家将添加到最终报告中
5.非格司亭（参考产品： Neupogen)
5.1。药物资料
5.2。产品总览
5.3。监管批准和启动
5.4。适应症
5.5。作用机理
5.6。剂量和给药
5.7。剂量与优势
5.8。剂量修改
5.9。合成路线
5.10。药理
5.11。药效学
5.12。药代动力学
5.13。不良反应
5.14。产品快照
5.15。发展历程
6.研究与发展
6.1。临床试验信息
6.2。安全与功效
7. Neupogen生物仿制药： 新兴机会
8. 菲格拉斯汀：生物仿制药评估
8.1。按产品类型评估
8.2。按行政途径评估
8.3。按分子类型评估
8.4。销售评估
9. 菲格拉斯汀生物仿制药简介：按公司
9.1.1。辉瑞
9.1.1.1。 尼维斯汀：辉瑞
9.1.1.1.1。产品信息
9.1.1.1.2。研究与开发
9.1.1.1.3。其他发展活动
9.1.1.1.4。概述表
9.1.2。诺华
9.1.2.1。 扎尔西奥：诺华
9.1.2.1.1。产品信息
9.1.2.1.2。研究与开发
9.1.2.1.3。其他发展活动
9.1.2.1.4。概述表
9.1.3。 Zydus卡迪拉
9.1.3.1。 脑脊液：Zydus Cadila
9.1.3.1.1。产品信息
9.1.3.1.2。研究与开发
9.1.3.1.3。其他发展活动
9.1.3.1.4。概述表
9.1.4。 Bio-Ker
9.1.4.1。 BK 0023：Bio-Ker
9.1.4.1.1。产品信息
9.1.4.1.2。研究与开发
9.1.4.1.3。其他发展活动
9.1.4.1.4。概述表
9.1.5。山多士
9.1.5.1。扎尔齐奥：桑多兹
9.1.5.1.1。产品信息
9.1.5.1.2。研究与开发
9.1.5.1.3。其他发展活动
9.1.5.1.4。概述表
*更多公司和产品将添加到最终报告中
10.菲格拉斯汀生物仿制药：比较情况：按公司
11. 菲格拉斯汀生物仿制药：竞争格局
11.1.1。总览
11.1.2。市场份额分析
11.1.3。竞争场景
11.1.3.1。产品发布和批准
11.1.3.2。伙伴关系，合作和协议
11.1.3.3。收购
11.1.3.4。扩展
11.1.3.5。生物制剂专利到期
*更多信息将添加到最终报告中
12.市场驱动力
13.市场壁垒
14. SWOT分析
15.附录
15.1。研究方法论
15.1.1。覆盖范围
15.1.2。二次研究
16.参考书目
17. DelveInsight功能
18.免责声明
19.关于DelveInsight
表清单
表1非拉西汀的总产品
表2后期产品
表3中期产品
表4早期产品
表5临床前&发现阶段产品
表6按产品类型评估
表7按阶段和产品类型评估
表8按管理途径评估
表9按管理阶段和途径进行的评估
表10按分子类型评估
表11按阶段和分子类型评估
表12无效产品
图清单
图1氟拉司汀的总产品
图2后期产品
图3中期产品
图4早期产品
图5临床前和发现阶段产品
图6按产品类型评估
图7按阶段和产品类型评估
图8按管理途径评估
图9按管理阶段和途径进行的评估
图10按分子类型评估
图11按阶段和分子类型评估
图12无效产品
