Comparison of the Physicochemical Properties and Clinical Efficacy of a Biosimilar Filgrastim with those of Reference Filgrastim
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- Category: Vol. 84, June 2016
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Comparison of the Physicochemical Properties and Clinical Efficacy of a Biosimilar Filgrastim with those of Reference Filgrastim, NAHLA S. KOTB and ABDHALLA A. TALEB
Abstract
Purpose: Biosimilars should provide safety, purity, and potency similar to those of a reference biologic product. To evaluate the similarities and differences in physicochemical and clinical efficacy between the biosimilar recombinant granulocyte colony stimulating factor available in the Egyptian market from Chinese country of origin with the innovator product, we performed a study to compare the effectiveness of Chinese biosimilar with reference filgrastim in FN preven-tion in patients receiving combination therapy of chronic HCV infection with pegylated interferon alfa and ribavirin.
Methods: This is a comparative randomized, double-blind parallel study enrolled 30 patients with chronic active hepatitis C, aged 20-41. Among them 12 were male and 18 female). Treatment regimen for chronic hepatitis C patients was as follows: Pegylated interferon alfa 2a (Pegasys) 180 micro kg or alfa 2b (PegIntron) 1, 5 micro g/kg. And ribavirin (RBV). The patients were divided into two groups: 15 patients (inno-vator group) besides combination antiviral therapy (pegylated interferon alfa plus ribavirin) systematically received innovator Filgrastim and other 15 patients (biosimilar group) besides combination antiviral therapy (pegylated interferon alfa plus ribavirin) systematically received biosimilar Filgrastim. Selection of patients was performed by computerized random-ization method.
Results: This study confirmed presence of significant difference between reference filgrastim group and biosimilar group in increasing total white blood cells (p=0.003), also there was a significant increase in total white blood cells in case of innovator group (p=.000) while for biosimilar group there was no significant difference before and after treatment (p=0.180).
Conclusion: The quality of Chinese biosimilar product is incomparable with reference filgrastim product which con-firmed the need for in-depth assessment of quality of biosim-ilars by local regulatory authorities together with regular physicochemical and biological analysis of the products, even when they are on the market, is necessary to monitor product quality, efficacy and evaluate potential immunogenic factors.