(Albany, US) Filgrastim Biosimilar Insight report on 20+ companies and 20+ marketed and pipeline drugs | DelveInsight
“Filgrastim Biosimilar Insight, 2020” by DelveInsight covers the marketed and pipeline drug profiles, including clinical and non-clinical stage products with Global coverage. It also includes the therapeutics assessment by product type, stage, route of administration, and molecule type. It further showcases the inactive pipeline products in this space.
Filgrastim Biosimilar Report Highlights
- The companies and academics are working to assess challenges and seek opportunities that could influence Filgrastim R&D. The therapies under development are focused on novel approaches to treat/improve Filgrastim.
- In November 2019, Sandoz announced that the US Food and Drug Administration (FDA) approved its biosimilar ZiextenzoTM (pegfilgrastim-bmez).
- In April 2019, Sandoz announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US Food and Drug Administration (FDA) to address an FDA complete response letter received in June 2016.
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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).
DelveInsight’s report provides analysis of several drugs in different clinical development stages, covering marketed, phase III, II, I, and preclinical. It also helps to comprehend clinical trial details, expressive pharmacological action, agreements, and collaborations.
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Filgrastim Biosimilars Marketed Drugs
- Nivestym: Pfizer
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: Apotex/Intas
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.
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Filgrastim Biosimilars Emerging Drugs
- TX-01: Tanvex Biopharma
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: Mycenax Biotech
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.
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Filgrastim Biosimilars Companies:
- Zydus Cadila
- Teva Generics
- Sandoz
- Reliance Life Sciences
- Ratiopharm
- Pfizer
- Novartis
- Mycenax Biotech
- Laboratorio Elea
- Hexal
- Harvest Moon Pharmaceuticals
- Harvest Moon Pharmaceuticals
- Hangzhou Jiuyuan Gene Engineering
- Fuji Pharmaceutical
- Mochida Pharmaceutical
- Gene Techno Science
- Emcure Pharmaceuticals
- Dr Reddy’s Laboratories
- Dong-A ST Co.
- Claris Lifesciences
- Bionovis
- Bionaturis
- Curaxys
- Bio-Ker
- Biocon
- Mylan
- Biocad
- Apotex
- Aequus
- CTI BioPharma
- Accord Healthcare
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