Also known as: filgrastim-sndz, G-CSF
Filgrastim is the original short-acting recombinant human granulocyte colony-stimulating factor (G-CSF), approved in the United States in 1991. It is used to reduce infection risk from chemotherapy-related febrile neutropenia and other neutropenia-related settings, including radiation-induced myelosuppression. It remains widely used alongside biosimilar products.
X4 Pharmaceuticals is on track to complete enrollment of its Phase 3 4WARD trial for mavorixafor in chronic neutropenia by Q3 2026, targeting a 2028 launch. The European Commission approved XOLREMDI for WHIM syndrome, while the company cuts costs and deprioritizes WHIM commercialization.
C4 Therapeutics has initiated its Phase 2 MOMENTUM trial of cemsidomide in relapsed/refractory multiple myeloma, targeting enrollment completion in Q1 2027 and a registrational dataset by 2028. The company plans a combination study with elranatamab in Q2 2026.
The global biosimilar market is experiencing robust growth, valued at USD 36.79 billion in 2024 and projected to reach USD 282.3 billion by 2035 at a CAGR of 20.35%, driven by patent expirations, cost pressures, and expanding access to biologic therapies.
The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen, for cancer patients at risk of infection due to chemotherapy and other indications. The approval marks Accord BioPharma's sixth biosimilar product.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07604233 |
Phase 1/2 FLAG-IDA, VEN and Asciminib in CML and Ph+ AML |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07585136 |
Stem Cell Mobilization and Apheresis for Life-threatening Blood Disorders |
NOT_YET_RECRUITING | PHASE1 |
| NCT07278856 |
Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas |
NOT_YET_RECRUITING | PHASE1 |
| NCT07257419 |
CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma |
RECRUITING | PHASE1 |
| NCT07224100 |
Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma |
RECRUITING | PHASE2 |
| NCT07064018 |
Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies |
RECRUITING | PHASE1/PHASE2 |
| NCT07059611 |
Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07052370 |
TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies |
RECRUITING | PHASE1 |
| NCT07012044 |
A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia |
RECRUITING | PHASE1 |
| NCT06942039 |
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation |
RECRUITING | EARLY_PHASE1 |
