Filgrastim
- Generic Name
- Filgrastim
- Brand Names
- Accofil, Granix, Grastofil, Neupogen, Nivestim, Nivestym, Ratiograstim, Releuko, Zarxio, Zarzio, Filgrastim Hexal, Tevagrastim
- Drug Type
- Biotech
- CAS Number
- 121181-53-1
- Unique Ingredient Identifier
- PVI5M0M1GW
- Background
Filgrastim is a short-acting recombinant, non-pegylated human granulocyte colony-stimulating factor (G-CSF) analog produced by recombinant DNA technology. It has an amino acid sequence identical to endogenous G-CSF, but it is non-glycosylated unlike the endogenous G-CSF and has an N-terminal methionine added in the sequence for expression in E. Coli. Human G-CSF is a glycoprotein that regulates the production and release of neutrophils from the bone marrow. Filgrastim mimics the biological actions of G-CSF to increase the levels of neutrophils in the blood. It has a number of therapeutic uses, including the management and prevention of infections and febrile neutropenia in patients receiving myelosuppressive chemotherapy or radiation therapy. It is also used to manage severe chronic neutropenia and mobilize hematopoietic progenitor cells to the peripheral blood for collection by leukapheresis in patients undergoing peripheral blood progenitor cell collection and therapy.
Filgrastim was approved in the US in 1991 and there are biosimilars available with similar therapeutic indications. Tbo-filgrastim was approved by the FDA on August 29, 2012. Filgrastim-sndz was approved on March 6, 2015 and filgrastim-ayow was approved on March 2, 2022. A long-acting, pegylated G-CSF, pegfilgrastim, was made available to increase the duration of action of the drug.
- Indication
Filgrastim is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
Filgrastim is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia.
Filgrastim is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation.
Filgrastim is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
Filgrastim is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.
Filgrastim is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
- Associated Conditions
- Congenital neutropenia, Cyclic neutropenia, Febrile Neutropenia, Hematopoietic Subsyndrome of Acute Radiation Syndrome, Idiopathic neutropenia, Infection, Neutropenia
- Associated Therapies
- Mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis therapy
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• The European Medicines Agency (EMA) has released a draft reflection paper outlining a simplified approval pathway for biosimilars that could reduce clinical data requirements while maintaining safety standards.
• The proposed approach focuses on structural and functional comparability along with pharmacokinetic data, potentially eliminating the need for extensive clinical efficacy studies in biosimilar development.
• If implemented in 2026 after the consultation period ends in September 2025, the streamlined process aims to increase market competition and improve patient access to critical biological treatments across the EU.
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• The FR𝛼-targeting antibody-drug conjugate showed consistent efficacy across all levels of FR𝛼 expression (≥25%), including patients with lower expression levels who aren't eligible for currently approved FR𝛼-targeting treatments.
• Despite the promising clinical data presented at SGO 2025, Sutro Biopharma has announced it is deprioritizing investment in luvelta's development and is seeking out-licensing opportunities to continue advancing the treatment.
Exicure Secures Australian Patent for Novel Cancer Treatment Targeting CXCR4 and GPCRx
• Exicure (NASDAQ: XCUR) has been granted Australian Patent No. 2018388302 for its innovative combination approach targeting CXCR4 and GPCRx in cancer treatment.
• The patent supports Exicure's ongoing Phase 2 clinical trial evaluating GPC-100 and propranolol combination in multiple myeloma patients, aiming to enhance hematopoietic stem cell mobilization.
• This intellectual property has already been secured in the United States, Japan, and Taiwan, strengthening Exicure's global patent portfolio for its proprietary co-targeting approach.
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• Recent clinical trials demonstrate that same-day administration of granulocyte colony-stimulating factors (G-CSFs) after chemotherapy is safe and effective in patients with early-stage breast cancer, potentially simplifying treatment protocols.
• Eflapegrastim (Rolvedon) administered on the same day as TC chemotherapy resulted in a mean duration of severe neutropenia of less than one day, with only one patient experiencing febrile neutropenia in a phase 1 study.
• Efbemalenograstim alfa-vuxw (Ryzneuta) given within 24 hours after chemotherapy showed a low incidence of grade 3/4 neutropenia (21.62%) across all cycles, with no serious treatment-related adverse effects reported.
Biosimilars Market Shows Mixed Progress: $36B in Savings Despite Adoption Challenges
• A decade after the first biosimilar approval, these drugs have generated $36 billion in healthcare savings, though adoption rates vary significantly across different molecules and therapeutic areas.
• Market dynamics show complex patterns, with some biosimilars achieving up to 89% market share, while others struggle below 40%, influenced by PBM policies and brand-name manufacturer strategies.
• The biosimilar landscape faces new challenges in 2025, with upcoming launches for Stelara and rare disease treatments, while PBM influence continues to shape market access and adoption patterns.
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• Phase 3 PRESERVE 1 trial demonstrates trilaciclib significantly reduced chemotherapy-induced neutropenia when combined with FOLFOXIRI/bevacizumab in metastatic colorectal cancer patients.
• The study showed notable safety benefits with trilaciclib, including complete prevention of febrile neutropenia and 52% reduction in G-CSF usage compared to placebo.
• Despite achieving primary myeloprotection endpoints, trilaciclib showed lower objective response rates (41.6% vs 57.1%) compared to placebo, raising questions about optimal treatment strategy.
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• Bevqolva is indicated for multiple cancers, including metastatic colorectal cancer, non-small cell lung cancer, renal cell carcinoma, cervical cancer, and ovarian cancers.
• The biosimilar will be available as a 25 mg/mL concentrate in 4 mL and 16 mL single-use vials, administered intravenously, offering a cost-effective alternative.
• This approval follows a positive opinion from the EMA's CHMP for Aurobindo Pharma's filgrastim biosimilar Zefylti, further strengthening its biosimilar portfolio.
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• The consolidation therapy includes decitabine and cytarabine, followed by UCB infusion, demonstrating manageable adverse events and encouraging remission rates.
• Single-cell RNA sequencing analysis suggests UCB infusion modulates the immune microenvironment, potentially enhancing anti-leukemic effects.
• These findings support UCB infusion as a feasible adjuvant strategy for elderly AML patients ineligible for allo-HSCT, warranting further investigation.
CuraTeQ Biologics' Zefylti (Filgrastim Biosimilar) Receives Positive CHMP Opinion for EU Approval
• CuraTeQ Biologics' Zefylti, a biosimilar of filgrastim, has received a positive opinion from the EMA's CHMP, recommending marketing authorization in the EU.
• Zefylti is indicated for the treatment of neutropenia and the mobilization of peripheral blood progenitor cells (PBPCs) in patients.
• This marks CuraTeQ's first biosimilar to receive a positive CHMP opinion after obtaining GMP certificate of compliance from the EMA in November.
• CuraTeQ has other biosimilars of pegylated filgrastim, trastuzumab and bevacizumab under review with EMA and MHRA, expected to be available next year.
Global Biosimilars Market Set to Triple to $114 Billion by 2031, Driven by Patent Expirations and Cost Advantages
• The global biosimilars market is projected to grow from $36.01 billion in 2024 to $114.02 billion by 2031, representing a robust CAGR of 17.9%, fueled by increasing demand for cost-effective biologics.
• Oncology biosimilars are emerging as a particularly strong segment, expected to reach $35.79 billion by 2034 with an 18.6% CAGR, as patent expirations of blockbuster cancer drugs create new market opportunities.
• Regulatory support from agencies like FDA and EMA is accelerating biosimilar adoption, with recombinant human growth hormone and granulocyte colony-stimulating factor segments leading market growth across therapeutic areas.
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• Treatment-free survival was estimated at 72% at 18 months, suggesting a durable response in responding patients treated with iopofosine I 131.
• While adverse events like thrombocytopenia and neutropenia were common, the study suggests iopofosine I 131 is a valuable option where standard treatments have failed.
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• Steqeyma and Yesintek are approved for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, mirroring Stelara's indications.
• These approvals are expected to increase market competition and reduce treatment costs, with launches anticipated in early 2025 following licensing agreements.
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• The study achieved a complete remission (CR) or CR with incomplete hematologic recovery (CRi) rate of 49% after induction therapy.
• Event-free survival (EFS) was 3.0 months, and overall survival (OS) was 7.4 months, with improved outcomes in patients undergoing stem cell transplantation.
• Researchers emphasize the need for more effective therapies for specific AML patient subgroups, despite CPX-351's potential.
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• A study shows that combining decitabine with the CHAG priming regimen yields a high complete remission rate (74.2%) in relapsed/refractory AML patients.
• The overall response rate was 82.2%, with manageable side effects and no treatment-related deaths, suggesting a potential new treatment strategy.
• The median relapse-free survival was 4.3 months, and the median overall survival was 7.75 months, warranting further investigation with larger studies.
• Decitabine combined with CHAG may offer deeper remissions, with a significant number of patients achieving MRD-negative status after treatment.
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• X4 Pharmaceuticals announced positive Phase 2 results for mavorixafor in chronic neutropenia (CN), demonstrating increased neutrophil counts.
• The Phase 3 4WARD trial of mavorixafor in CN is progressing, with full enrollment expected by mid-2025.
• XOLREMDI® (mavorixafor) U.S. launch for WHIM syndrome is underway, with EMA submission anticipated in early 2025.
• Market research indicates high awareness and increased screening for WHIM syndrome, supporting XOLREMDI adoption.
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• X4 Pharmaceuticals reported positive Phase 2 clinical data for mavorixafor in chronic neutropenia (CN), showing increased neutrophil counts.
• The Phase 2 study demonstrated that once-daily oral mavorixafor was well-tolerated and effectively elevated participants' neutrophil counts.
• X4's pivotal Phase 3 trial of mavorixafor in CN is progressing as planned, with full enrollment expected by mid-2025.
• The U.S. launch of XOLREMDI® (mavorixafor) for WHIM syndrome is underway, and EMA submission is anticipated by early 2025.
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• ME Therapeutics is progressing its anti-G-CSF antibody candidate, h1B11-12, towards first-in-human clinical trials, with GMP production anticipated in the second half of 2025.
• The company is also establishing a new lab to enhance research programs and explore early-stage drug discovery, planning to expand its scientific research staff.
• ME Therapeutics is actively pursuing in-licensing and partnership opportunities to strengthen its drug development pipeline in immuno-oncology.
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• Sacituzumab govitecan shows significant efficacy but presents management challenges with cytopenias, particularly in heavily pretreated patients, often requiring G-CSF support.
• Back-to-back ADC administration appears effective, with experts noting no benefit to sandwiching conventional chemotherapy between ADC treatments.
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• The FDA has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment for transplant-ineligible multiple myeloma.
• The approval was based on the IMROZ phase 3 trial, which showed a 40% reduction in disease progression or death compared to VRd alone.
• Sarclisa is the first anti-CD38 therapy approved with VRd for this patient population, offering a new standard of care.
• The combination demonstrated high rates of complete response and minimal residual disease negativity, improving long-term outcomes.
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• Agios Pharmaceuticals' tebapivat (AG-946) has been granted FDA orphan drug designation for treating myelodysplastic syndromes (MDS).
• The designation provides incentives like tax credits and potential market exclusivity for rare disease treatments.
• Tebapivat aims to be the first oral therapy for anemia in lower-risk MDS, affecting 75,000-80,000 patients in the U.S. and EU5.
• Agios has completed a Phase 2a study and is initiating a Phase 2b study of tebapivat in lower-risk MDS.
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