Leucostim (rhG-CSF biosimilar) / Biocad, Hikma, Dong-A - LARVOL DELTA

Towards a comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars in treating chemotherapy associated febrile neutropenia: Trends from decades of data. (PubMed, Toxicol Appl Pharmacol) - "Filgrastim, a biopharmaceutical listed on WHO model list of essential medicines, was approved in USA in 1991 for patients with non-myeloid malignancies associated with severe neutropenia and fever...Overall, 11,183 adverse drugs reaction reports were identified during observation period; of which 5764; 51.5% reports concerned to Neupogen®, the originator, and rest consists of Leucostim® (N = 680), Zarzio® (N = 622), Grasin® (N = 545), Nivestim® (N = 359) and Tevagrastim® (N = 152) biosimilars...Authors observed significant differences among originator and biosimilars in particular to efficacy, adverse events reported and time to onset of occurrences. Large epidemiologic studies are needed to further confirm these finding and provide additional insights."

Journal • Back Pain • Hematological Disorders • Musculoskeletal Pain • Neutropenia • Oncology • Pain

Construction of a Pichia pastoris strain efficiently producing recombinant human granulocyte-colony stimulating factor (rhG-CSF) and study of its biological activity on bone marrow cells. (PubMed, Mol Biol Rep) - "Non-glycosylated, recombinant human granulocyte colony-stimulating factor (rhG-CSF), produced by Escherichia coli (filgrastim, leukostim) is widely used to treat a number of serious human diseases and aids in the recovery post bone marrow transplantation. The P. pastoris strain was designed to produce relatively high levels of rhG-CSF. The rhG-CSF protein had a strong stimulating effect on the growth of rat bone marrow cells, which was comparable to that of the commercial drug leukostim, but showed a more persistent effect on granulocyte cells and monocyte sprouts, enabling the enhanced maintenance of the viability of the cells into the 4th day of incubation."

Journal • Transplantation

Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen® (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: Biocad

New P1 trial • Biosimilar

Intrauterine G-CSF Administration in Recurrent Implantation Failure (RIF): An Rct. (PubMed, Sci Rep) - "The procedure was performed by administering 30 mIU of Leucostim®(Filgrastim [G-CSF] 30 mIU/mL; DEM Medical, Dong-A; South Korea) through slow infusion into the endometrial cavity using a soft embryo transfer catheter. No statistically significant difference was identified in clinical pregnancy rates, miscarriage rates and live birth rates between the G-CSF group and the control group (p = 0.112, p = 0.171, p = 0.644, respectively), and no difference was observed between the two groups regarding endometrial thickness (p = 0.965). The intervention of administration G-CSF into the uterine cavity in RIF patients with normal endometrium, did not alter the endometrial thickness, clinical pregnancy rates, or live birth rates."

Journal • CSF3

A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients (clinicaltrials.gov) - P3; N=143; Completed; Sponsor: Dong-A ST Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion

G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy (clinicaltrials.gov) - P2; N=88; Recruiting; Sponsor: Hanyang University Seoul Hospital

Clinical • New P2 trial

Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy (clinicaltrials.gov) - P4; N=60; Not yet recruiting; Sponsor: Hyuk moon Kim

Clinical • New P4 trial

The Comparison of The Efficacy and Safety of Original and Biosimilar Filgrastim in Prevention of Chemotherapy-Induced Neutropenia in Children with Cancer. (PubMed, Eurasian J Med) - "Although the mean WBC counts on days 1 and 5 were lower in Group A, the difference was statistically insignificant. The biosimilar filgrastim, Leucostim, is as effective and safe as the original drug for prophylaxis of chemotherapy-induced neutropenia in children."

Clinical • Journal