Also known as: Neulasta, Udenyca
Pegfilgrastim is a long-acting granulocyte colony-stimulating factor biologic used to stimulate neutrophil recovery and reduce infection risk after myelosuppressive chemotherapy. It is also used for hematopoietic acute radiation syndrome. The reference product Neulasta received FDA approval in 2002.
Lupin reported record Q3 FY2026 revenue of INR 7,168 crores and a 31.1% EBITDA margin, while preparing to launch a generic semaglutide and shifting focus to innovation. The company also secured US FDA approval for Pegfilgrastim and EU approval for ranibizumab biosimilar.
Two separate clinical trials have reported advances in cancer care. An oral drug combination of decitabine-cedazuridine and venetoclax showed efficacy in older patients with acute myeloid leukemia, with a 47% complete response rate in a phase 2b trial. A separate randomized controlled trial found that delaying pegfilgrastim administration to 72 hours post-chemotherapy significantly reduced bone pain in women with stage I–III breast cancer.
Lupin Limited reported strong Q3 FY26 results with total sales of ₹71,005 million, up 26% year-over-year, and received US FDA approval for its pegfilgrastim biosimilar Armlupeg™, which has not yet been launched.
The FDA has accepted Dr. Reddy's Laboratories' BLA for DRL_AB, a proposed interchangeable biosimilar to abatacept, submitted in December 2025. The application is the first for an abatacept biosimilar and is supported by Phase 1 data showing pharmacokinetic similarity.
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 |
|---|---|---|---|
| NCT07278856 |
Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas |
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 |
| NCT07021989 |
ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma |
RECRUITING | PHASE2 |
| NCT06738368 |
Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia |
RECRUITING | PHASE2 |
| NCT06709495 |
Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas |
RECRUITING | PHASE1/PHASE2 |
| NCT06528691 |
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors |
RECRUITING | PHASE2 |
| NCT06520176 |
Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients |
RECRUITING | PHASE3 |
| NCT06309732 |
GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT) |
COMPLETED | PHASE2 |
