PEG-Filgrastim (PEG-GCSF) is a pegylated form of GCSF which has a higher serum half-life than GCSF. Pegfilgrastim is administered to patients with certain kinds of cancer to accelerate recovery from chemotherapy induced neutropenia.. USV’s PEG-GCSF has been produced using non-infringing aqueous based PEGylation and purification technology. PCT application has been filed for the same.
- Comparative physico-chemical characterization against reference product Neulasta® of Amgen carried out
- Non-clinical comparability studies conducted successfully in Europe based on the following guidelines:
- Guideline on Similar Biological Medicinal Products containing Biotechnology- Derived Proteins as Active Substance: Non-Clinical and Clinical Issues (EMEA/CHMP/BMWP/42832/2005)
- ICH guideline S6 (R1) Preclinical safety evaluation of biotechnology-derive pharmaceuticals.
- Phase I Clinical Studies in Europe completed based on the following guidelines:
- ICH Guideline E6(R1) Guideline for Good Clinical Practice
- Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active
Substance: Non-Clinical and Clinical Issues (EMEA/CHMP/BMWP/42832/2005)
- Phase III Clinical Studies in Europe initiated in September 2015 as per EMEA guidelines.
- Pre IND meeting with USFDA held. Phase I in US planned.
- Approval received from DCGI to initiate phase III clinical studies in India.
- Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
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