filgrastim
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chemotherapy-induced toxicity 2 milestones | |||||
| Filed | Other | — | chemotherapy-induced toxicity | 2019-01-16 | “announce its New Drug Submission (NDS) to the Health Canada for filgrastim.” tanvex.com ↗ |
| Filed | US (FDA) | — | chemotherapy-induced toxicity | 2018-11-28 | “Back on November 2018, the US Food and Drug Administration (FDA) accepted Tanvex BioPharma’s Biologics License Application (BLA) for TX-01 (filgrastim)” tanvex.com ↗ “announced that US Food and Drug Administration (FDA) has accepted its Biologics License Application for filgrastim (TX- 01)” tanvex.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Filed | US (FDA) | — | — | 2020-11-22 | “announced that we resubmitted the Biologics License Application (BLA) for filgrastim (TX-01) to US Food and Drug Administration (FDA).” tanvex.com ↗ |
| Label expansion | US (FDA) | GRANIX | — | 2018-07-31 | fda.gov ↗ |
| Label expansions (5) | US (FDA) | NEUPOGEN | — | 1994-06-15 – 2015-03-30 | fda.gov ↗ |
| Approved | EU (EMA) | Tevagrastim | — | 2008-09-15 | europa.eu ↗ |
| Approved | US (FDA) | NEUPOGEN | — | 1991-02-20 | fda.gov ↗ |
Trials 171 · started per year
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2024-07-01 | Tanvex BioPharma USA, Inc. | Regulatory Tanvex received BLA approval from FDA tanvex.com ↗
The U.S. Food and Drug Administration (FDA) had completed their review of our submission of NYPOZI (TX01) and approved the biologics license application (BLA) on June 28, 2024. |
| 2022-03-01 | Impax Laboratories, LLC | Regulatory Amneal Enters U.S. Biosimilars Market With Approval of RELEUKO<sup>®</sup> (filgrastim-ayow) amneal.com ↗
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of the Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen ® . |
| 2021-10-17 | Tanvex BioPharma USA, Inc. | Regulatory Tanvex received marketing authorization from Health Canada tanvex.com ↗
Tanvex BioPharma, Inc. (TWSE: 6541) announced that Health Canada had completed their review of our submission of NYPOZI (TX01) and granted marketing authorization. |
| 2021-05-21 | Tanvex BioPharma USA, Inc. | Regulatory FDA delayed inspection for TX01 tanvex.com ↗
Tanvex BioPharma, Inc. announced that it received a complete response letter (CRL) from United States Food and Drug Administration (FDA) in response to the Biologics License Application (BLA) for TX01, a proposed biosimilar to Neupogen® (filgrastim). |
| 2020-11-22 | Tanvex BioPharma USA, Inc. | Regulatory TX01 BLA Resubmission tanvex.com ↗
Tanvex BioPharma, Inc. (TWSE: 6541) announced that we resubmitted the Biologics License Application (BLA) for filgrastim (TX-01) to US Food and Drug Administration (FDA). |
| 2020-11-17 | Tanvex BioPharma USA, Inc. | Regulatory Tanvex submits TX01 NDS responses to Health Canada tanvex.com ↗
Tanvex BioPharma, Inc. (TWSE: 6541) announced the submission of TX01 New Drug Submission (NDS) responses to Health Canada. |
| 2019-09-25 | Tanvex BioPharma USA, Inc. | Regulatory Response from FDA for TX01 tanvex.com ↗
Tanvex BioPharma, Inc. announced that it received a complete response letter (CRL) from United States Food and Drug Administration (FDA) in response to the Biologics License Application (BLA) for TX01, a proposed biosimilar to Neupogen® (filgrastim). |
| 2019-03-11 | Tanvex BioPharma USA, Inc. | Regulatory Canada Accepts Tanvex NDS submission for TX01 tanvex.com ↗
Today, we are pleased to announce that the submission has been accepted for review by Health Canada. |
| 2019-01-16 | Tanvex BioPharma USA, Inc. | Regulatory Tanvex submits NDS for TX01 to Health Canada tanvex.com ↗
Today, Tanvex BioPharma, Inc. (TWSE: 6541) is proud to also announce its New Drug Submission (NDS) to the Health Canada for filgrastim. |
| 2018-11-28 | Tanvex BioPharma USA, Inc. | Regulatory FDA Accepts TX01 BLA Filing tanvex.com ↗
FDA Accepts TX01 BLA Filing |
| 2018-10-01 | Tanvex BioPharma USA, Inc. | Regulatory Tanvex BioPharma Submits its First Biologics License Application to U.S. FDA For TX-01 tanvex.com ↗
Tanvex BioPharma, Inc. (TWSE: 6541) announced the submission of its biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for TX-01, a proposed biosimilar to the reference product Neupogen® (filgrastim) which is indicated for chemotherapy induced neutropenia. |
| 2018-08-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Updated Indication and Vial Presentation for GRANIX® (tbo-filgrastim) Injection in United States tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved GRANIX® (tbo-filgrastim) Injection for a new vial presentation and indication in pediatric patients 1 month and older. |
| 2018-07-20 | Pfizer | Regulatory U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™ (filgrastim-aafi) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen 1 (filgrastim), for all eligible indications of the reference product. |
| 2017-08-24 | Tanvex BioPharma USA, Inc. | Results TX01 Press Release tanvex.com ↗
All PK and PD parameters met the bioequivalence criteria (the 90% confidence interval of the ratio of the mean of TX01 vs. Neupogen lies completely within 80-125%). |
| 2015-03-06 | Novartis Pharmaceuticals | Regulatory FDA approves first biosimilar ZarxioTM (filgrastim-sndz) from Sandoz novartis.com ↗
Sandoz, a Novartis company, announced today that the US Food and Drug Administration (FDA) approved Zarxio(TM) (filgrastim-sndz) for all indications included in the reference product's label. |
| 2015-01-07 | Novartis Pharmaceuticals | Regulatory Sandoz biosimilar filgrastim recommended for approval by FDA Oncologic Drugs Advisory Committee novartis.com ↗
FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of its investigational biosimilar filgrastim in the US. |
| 2014-12-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory FDA Approves Teva’s GRANIX® (tbo-filgrastim) Injection for Self-Administration tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved GRANIX® (tbo-filgrastim) Injection for self-administration by patients and caregivers. |
| 2013-01-25 | Kyowa Kirin, Inc. | Results Results of Phase 3 Clinical Trials of KRN125 in Patients with Malignant Lymphoma and Breast Cancer in Japan kyowakirin.com ↗
As a result, non-inferiority of KRN125 to filgrastim was confirmed. |
| 2012-08-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Grants Approval for Tbo-filgrastim for the Treatment of Chemotherapy-Induced Neutropenia tevapharm.com ↗ |
| 2010-02-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Accepts BLA for XM02 tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva's Biologics License Application (BLA) for XM02 |
| 2009-12-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces The Submission Of A Biologics License Application (BLA) For XM02 For The Treatment Of Chemotherapy-Induced Neutropenia tevapharm.com ↗ |
| 2008-09-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives EU Marketing Authorization for TevaGrastim® tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the European Commission's Directorate General for Enterprise and Industry granted Teva a Marketing Authorization for its human granulocyte colony stimulating factor (G-CSF) product. |
| 2008-02-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva's Developed G-CSF is the First Biosimilar to Receive a Positive Opinion from European Union Regulators tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today the receipt of a positive opinion from the CHMP, the scientific committee of the European Medicines Agency ("EMEA"), for its human granulocyte colony stimulating factor ("G-CSF") product. |
All press releases naming this drug 27 releases
Evidence & citations 39 cited values
Every value below carries the sentence it was read from. 996 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | filgrastim | “One or more of the following may be assigned by the physician (physician's choice) per standard of care guidelines upon study enrollment following surgery: Cytarabine,...” NCT06861244 ↗954“The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better...” NCT00103610 ↗ “granulocyte colony-stimulating factor (G-CSF; filgrastim, Neupogen®) has been shown to shorten the duration of severe neutropenia, fever, antibiotic use and hospitalization...” NCT02282215 ↗ “Colony-stimulating factors, such as filgrastim-sndz, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover...” NCT00801489 ↗ “Patients randomised to G-CSF during induction treatment (Rapid COJEC) received a single daily subcutaneous injection of 5 microgram/kg/day G-CSF (filgrastim) beginning 24 hours...” NCT01704716 ↗ “The purpose of this pilot study is to evaluate the immunologic and the clinical response to granulocyte-colony stimulating factor (G-CSF, Filgrastim, Neupogen) administered to...” NCT00025805 ↗ “Filgrastim (300 μg for patients ≤ 70 kg or 480 μg for patients \> 70 kg) will be administered beginning two days after each cyclophosphamide dose and given for a total of eight...” NCT00003659 ↗ “A total of 170 lymphoma patients who are eligible are planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day...” NCT04460508 ↗ “As part of standard care, you will receive G-CSF (filgrastim) as an injection just under your skin 1 time a day starting on Day +5 until your blood cell levels return to normal.” NCT01421173 ↗ “Pegylated GCSF (PEG-GCSF) (e.g. pegfilgrastim) on-body injector (OBI) or daily GCSF (e.g. filgrastim) will be given according to institutional policy after Day 5 of topotecan.” NCT02649673 ↗ “Peripheral blood stem cells will be mobilized by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labeled with technetium.” NCT00629018 ↗ |
| Known as | AX200 | “Granulocyte colony-stimulating factor (G-CSF; AX200; Filgrastim) is a stroke drug candidate with excellent preclinical evidence for efficacy.” PMID 23963331 ↗ Aug 2013 |
| Known as | biosimilar filgrastim | “biosimilar filgrastim” NCT06116734 ↗ |
| Known as | Filgrastim Hospira | “the proposed biosimilar Filgrastim Hospira (US) and the US-approved Neupogen reference product” NCT02923791 ↗ |
| Known as | Filgrastim Megalabs | “Filgrastim Megalabs injectable 5 μg/Kg/day in a single subcutaneous application during 5 days” NCT04958772 ↗ |
| Known as | Filgrastim, Neupogen | “Filgrastim, Neupogen®” NCT02918292 ↗ |
| Known as | filgrastim-aafi | “PF-06881893 (filgrastim-aafi; Nivestym™), a filgrastim biosimilar” PMID 30900158 ↗ Apr 2019 |
| Known as | Filgrastim-sndz | “filgrastim-sndz” NCT02703779 ↗ |
| Known as | filigrastin | “The G-CSF (filigrastin) will be administered by intravenous way with the amount of 10 µg/kg/day during 3 days” NCT00213759 ↗ |
| Known as | G-CSF | “The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better...” NCT00103610 ↗168“Patients receive cytoreduction and mobilization of peripheral blood stem cells (PBSC) with filgrastim (G-CSF) and cyclophosphamide/paclitaxel, cyclophosphamide/etoposide or...” NCT00002977 ↗ “After an initial harvest of filgrastim (G-CSF)-mobilized autologous peripheral blood stem cells (PBSC) for transplantation, patients receive one additional dose of G-CSF and...” NCT00006225 ↗ “The purpose of this pilot study is to evaluate the immunologic and the clinical response to granulocyte-colony stimulating factor (G-CSF, Filgrastim, Neupogen) administered to...” NCT00025805 ↗ “Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 2 days after completion of cyclophosphamide and continuing until autologous peripheral blood stem cells...” NCT00002680 ↗ “Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 4 days prior to peripheral blood stem cell (PBSC) collection and continuing until the target number of...” NCT00020410 ↗ “Beginning at least 4 weeks prior to the start of chemotherapy, patients receive filgrastim (G-CSF) subcutaneously daily until the completion of peripheral blood stem cell...” NCT00002601 ↗ “Patients also receive sargramostim (GM-CSF) subcutaneously (SC) alone on days 3-9 and GM-CSF and filgrastim (G-CSF) SC beginning on day 10 and continuing until leukapheresis is...” NCT00027937 ↗ “Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 4 days prior to peripheral blood stem cell (PBSC) mobilization and continuing until adequate PBSC are collected.” NCT00008021 ↗ “This study will compare the combination of meloxicam with a drug called G-CSF (also called neupogen), to the combination of G-CSF with an agent that has no medicine (placebo).” NCT02003625 ↗ “Patients in dose levels 5 and above also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing for at least 7 days or until blood counts recover.” NCT00004212 ↗ |
| Known as | G-CSF (Filgrastim) | “G-CSF (Filgrastim)” NCT00592111 ↗ |
| Known as | Gracinᵀᴹ | “Filgrastim (Gracinᵀᴹ) is administered at the D3, D5, D7, D9, and D11 of each cycle.” NCT02685111 ↗ |
| Known as | Granix | “Granix” NCT04154735 ↗ |
| Known as | Granix (tbo-filgrastim) | “Granix (tbo-filgrastim)” NCT02282215 ↗ |
| Known as | Granulocyte colony-stimulating factor | “Granulocyte colony-stimulating factor (G-CSF; AX200; Filgrastim) is a stroke drug candidate with excellent preclinical evidence for efficacy.” PMID 23963331 ↗ Aug 20136“mobilization chemotherapy followed by filgrastim (granulocyte colony-stimulating factor; G-CSF).” NCT00002788 ↗ “patients receive subcutaneous filgrastim (granulocyte colony-stimulating factor; G-CSF).” NCT00003183 ↗ “granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim)” NCT00103662 ↗ “granulocyte colony-stimulating factor (G-CSF, A.K.A. Filgrastim)” NCT06174298 ↗ “Filgrastim (granulocyte-colony stimulating factor; G-CSF)” NCT00000801 ↗ “Granulocyte colony-stimulating factor (Filgrastim)” NCT02814110 ↗ |
| Known as | Granulocyte colony-stimulating factor (G-CSF), filgrastim (Neupogen) | “Granulocyte colony-stimulating factor (G-CSF), filgrastim (Neupogen®)” NCT02128230 ↗ |
| Known as | Granulokine | “Filgrastim (Granulokine, Amgen)” NCT01079676 ↗ |
| Known as | Grastofil | “Biosimilar filgrastim or Grastofil® (one dose for 5 days)” NCT06116734 ↗ |
| Known as | hrG-CSF | “Single subcutaneous injection of Filgrastim (hrG-CSF) 300 microg (30 MU)” NCT01102699 ↗ |
| Known as | KRN8601 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05007652 ↗ |
| Known as | Leucostim | “Neupogen®(Filgrastim) 5 ㎍/kg or Leucostim®(Filgrastim) 5 ㎍/kg will be administered subcutaneously on Period 1, Day 1.” NCT02725086 ↗ |
| Known as | Neupogen | “Filgrastim is a recombinant human G-CSF (rhG-CSF) developed in the mid 1980s, and was approved by the United States (US) Food and Drug Administration (FDA) for use in...” NCT00497809 ↗34“The purpose of this pilot study is to evaluate the immunologic and the clinical response to granulocyte-colony stimulating factor (G-CSF, Filgrastim, Neupogen) administered to...” NCT00025805 ↗ “This study will compare the combination of meloxicam with a drug called G-CSF (also called neupogen), to the combination of G-CSF with an agent that has no medicine (placebo).” NCT02003625 ↗ “Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN \> 0.5 G/L)” NCT00794261 ↗ “Neupogen®(Filgrastim) 5 ㎍/kg or Leucostim®(Filgrastim) 5 ㎍/kg will be administered subcutaneously on Period 1, Day 1.” NCT02725086 ↗ “Patients will receive hematopoietic growth factor support with either Leukine (Arm A), or Neupogen (Arm B).” NCT00237575 ↗ “FILGRASTIM: G-CSF (NEUPOGEN®) is administered as a short IV infusion over 30 minutes or subcutaneously.” NCT00228813 ↗ “recombinant granulocyte colony stimulating factor rG-CSF (Filgrastim, Neupogen®, Amgen Switzerland)” NCT00596479 ↗ “Filgrastim (also known as NEUPOGEN® or G-CSF) is approved by the FDA for stem cell mobilization.” NCT00066092 ↗ “Before the transplant the research participant will receive daily G-CSF (Neupogen) for 5-6 days.” NCT00058578 ↗ “GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim” NCT00658385 ↗ |
| Known as | Neupogen (filgrastim) | “Neupogen (filgrastim)” NCT02282215 ↗1“NEUPOGEN (Filgrastim)” NCT01202643 ↗ |
| Known as | NEUPOGEN (R) | “ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination” NCT00400556 ↗ |
| Known as | Neupogen(Registered) | “Multiple Subcutaneous (SC) Doses Of "Filgrastim Hospira" (US) Or US-approved Neupogen(Registered) Reference Product In Healthy Volunteers” NCT02923791 ↗ |
| Known as | Nivestym | “PF-06881893 (filgrastim-aafi; Nivestym™), a filgrastim biosimilar” PMID 30900158 ↗ Apr 2019 |
| Known as | NSC-614629 | “Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer” NCT00041067 ↗ |
| Known as | PF-06881893 | “PF-06881893 (filgrastim-aafi; Nivestym™), a filgrastim biosimilar” PMID 30900158 ↗ Apr 2019 |
| Known as | r-met HuG-CSF | “Frequently, Filgrastim (r-met HuG-CSF) is administrated alone; however, Filgrastim combined with chemotherapy has proven more effective in context of CD34+ cell numbers harvested” NCT01016795 ↗ |
| Known as | Recombinant Human Granulocyte Colony-Stimulating Factor | “Recombinant Human Granulocyte Colony-Stimulating Factor Injection (5μg/kg/day) will be injected subcutaneously at 10 am (±90 min) from the 3rd of per chemotherapy cycle.” NCT03251768 ↗4“Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 μg/day, to be discontinued when neutrophils recover and white blood cell count is ≥20,000/μL” NCT07514936 ↗ “Recombinant human granulocyte colony stimulating factor injection, 5 μg/kg, SC, from day 0 to stop of chemotherapy after the WBC count exceeds 10.0×10\^9/L;” NCT04541277 ↗ |
| Known as | rG-CSF | “recombinant granulocyte colony stimulating factor rG-CSF (Filgrastim, Neupogen®, Amgen Switzerland)” NCT00596479 ↗ |
| Known as | rhG-CSF | “Neupogen (rhG-CSF) Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion” NCT00776165 ↗2“Recombinant Human Granulocyte Colony-Stimulating Factor (rhG-CSF)” NCT07865650 ↗ “Filgrastim(rhG-CSF, TOPNEUTER)” NCT01238562 ↗ |
| Known as | tbo-filgrastim | “In retrospective studies, stem cell mobilization with tbo-filgrastim has shown similar efficacy and toxicity as filgrastim, but no prospective studies have been published to date.” PMID 28797783 ↗ Aug 20175“Tbo-filgrastim will be administered as follows: WBC count \>50,000 - 5mcg/kg; WBC count \<50,000 - hold Tbo-filgrastim.” NCT05780879 ↗ “Granix (tbo-filgrastim)” NCT02282215 ↗ |
| Known as | TOPNEUTER | “Filgrastim(rhG-CSF, TOPNEUTER)” NCT01238562 ↗ |
| Known as | US-Approved Neupogen | “the proposed biosimilar Filgrastim Hospira (US) and the US-approved Neupogen reference product” NCT02923791 ↗ |
| Known as | US-Neupogen | “reference product (filgrastim; US-Neupogen®)” PMID 30900158 ↗ Apr 2019 |
| Known as | Zarxio | “Zarxio” NCT00801489 ↗ |
| Modality | Protein / enzyme biologic | “filgrastim ( recombinant-methionyl human granulocyte-colony stimulating factor; G-CSF )” NCT00002126 ↗ |
| Route | Subcutaneous | “Patients are randomized to receive subcutaneous G-CSF at one of two different doses or no G-CSF (observation) for 24 weeks.” NCT00002126 ↗ |