Filgrastim - Biosimilar Insight, 2020
本報告提供全球各國Filgrastim的生物相似藥的疫情趨勢與今後預測相關分析，市場基本結構和最新形勢，整體臨床實驗的進展 (各階段的產品數等)，主要的已上市/開發中產品 (20種以上)的特徵和臨床實驗情形，主要企業 (20家公司以上)的簡介的主力商品，主要的治療藥的評估 (各產品種類、各臨床實驗階段、各給藥途徑、各分子類型)等資訊彙整，為您概述為以下內容。
DelveInsight's , "Filgrastim- Biosimilar Insight, 2020," report provides comprehensive insights about 20+ companies and 20+ marketed and pipeline drugs in Filgrastim 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.
Filgrastim, 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). Filgrastim is a growth factor that stimulates the production, maturation, and activation of neutrophils (a type of white blood cell). Filgrastim 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).
Filgrastim Biosimilars: Drugs Chapters
This segment of the Filgrastim 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.
Filgrastim Biosimilars: Marketed Drugs
Nivestym is a leukocyte growth factor that primarily stimulates neutrophils. The G-CSF 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, Pfizer 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.
Grastofil 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 Grastofil are similar in adults and children receiving cytotoxic chemotherapy. Grastofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). The active substance in Grastofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). Filgrastim acts in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Further product details are provided in the report.
Filgrastim Biosimilars: Emerging Drugs
Tanvex Biopharma is developing Filgrastim 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.
GranNEX is Mycenax's filgrastim, the biosimilar version of Neupogen, and the recombinant human granulocyte colony-stimulating factor, G-CSF. It can stimulate the growth of the white cell. The development of GranNEX 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 GranNEX's pre-clinical development and will focus on the application of the new delivery system or new formulation for patient's ease of using GranNEX.
Further product details are provided in the report.
Filgrastim: Therapeutic Assessment
This segment of the report provides insights about the different Filgrastim biosimilars segregated based on following parameters that define the scope of the report, such as:
There are approx. 20+ key companies which are developing the therapies for Filgrastim.
DelveInsight's report covers around 20+ products under different phases of clinical development like
Filgrastim pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
Products have been categorized under various Molecule types such as
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
Filgrastim: Pipeline Development Activities
The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Filgrastim biosimilars drugs key players involved in developing key drugs.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Filgrastim biosimilar drugs.
Current Treatment Scenario and Emerging Therapies:
More Countries would be added in the final report
More Companies and products would be added in the final report
More information would be added in the final report