Leucostim (rhG-CSF biosimilar) / Biocad, Hikma, Dong-A 
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 16 Diseases   0 Trials   0 Trials   34 News 
  • ||||||||||  Neupogen (filgrastim) / Kyowa Hakko Kirin, Roche, Amgen
    Journal:  Intrauterine G-CSF Administration in Recurrent Implantation Failure (RIF): An Rct. (Pubmed Central) -  Nov 26, 2020   
    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.
  • ||||||||||  Zarzio (filgrastim biosimilar) / Novartis
    Journal:  Towards a comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars in treating chemotherapy associated febrile neutropenia: Trends from decades of data. (Pubmed Central) -  Aug 18, 2020   
    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.
  • ||||||||||  Leucostim (rhG-CSF biosimilar) - Biocad, Hikma, Dong / A
    Trial completion:  A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim (clinicaltrials.gov) -  Dec 23, 2019   
    P3,  N=143, Completed, 
    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. Recruiting --> Completed
  • ||||||||||  Leucostim (rhG-CSF biosimilar) - Biocad, Hikma, Dong / A
    New trial:  Intrauterine G-CSF Administration in RIF (clinicaltrials.gov) -  Dec 20, 2018   
    P=N/A,  N=157, Completed, 
  • ||||||||||  Leucostim (rhG-CSF biosimilar) - Biocad, Hikma, Dong / A
    Trial completion:  Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim (clinicaltrials.gov) -  Dec 19, 2018   
    P1,  N=60, Completed, 
    The biosimilar filgrastim, Leucostim, is as effective and safe as the original drug for prophylaxis of chemotherapy-induced neutropenia in children. Not yet recruiting --> Completed
  • ||||||||||  Leucostim (rhG-CSF biosimilar) - Biocad, Hikma, Dong / A
    Trial completion date, Trial primary completion date:  A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim (clinicaltrials.gov) -  Dec 14, 2018   
    P3,  N=140, Recruiting, 
    Not yet recruiting --> Completed Trial completion date: Oct 2018 --> Aug 2019 | Trial primary completion date: Aug 2018 --> Dec 2018