Pegfilgrastim (as Prefilled Syringe - PFS)
Pegfilgrastim (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.
- Two Phase I Clinical Studies completed in Europe as per EMEA guidelines
- First Phase 1 at therapeutic dose
- Second Phase 1 at low dose
- Phase III Clinical Studies in Europe competed as per EMEA guidelines
- Dossier submitted to EMA in Q4 2017 and the same has been accepted for review
- Pre IND meeting with USFDA held.
- BPD Type 2 meeting with USFDA completed in Oct 2016
- Phase III Safety and Efficacy study completed.
- 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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