1 Department of Biologics, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Govt. India, Sector-23, Raj Nagar, Ghaziabad-201 002, India.
2 Department of Biotechnology, Bennett University, India
Abstract
Background: Filgrastim bio-similar have emerged as cost-effective alternatives to the reference filgrastim, providing comparable efficacy and safety profiles. Objective: In this study, we aim to show physico-chemical similarity between filgrastim biosimilars using vertical gel electrophoresis & high-performance liquid chromatography. Materials & Methods: In the present study, we evaluate filgrastim biosimilars (grafeel, religrast, neukine, colstim, emigrast) via SDS-PAGE and HPLC thereby checking their molecular weights for similarity and their qualitative analysis. The same was compared with reference standard of filgrastim (Filgrastim, certified Reference Material). Results: In the scope of the data obtained, we found that the main band of filgrastim in filgrastim biosimilars has the same electrophoretic mobility as the reference standard under non-reduced circumstances in case of SDS-PAGE, the outcomes demonstrated that the position of the principal band in the electropherogram produced by the test solution and the principal band produced by the reference solution are similar. The retention time of the main peak obtained with the test solution and the peak obtained with the reference solution are similar. For HPLC, all the filgrastim biosimilars showed monomer peaks on the RP-HPLC chromatograms, which eluted at 12.4 minutes, matching the retention duration of the filgrastim reference standard. Conclusion: Filgrastim has transformed the management of neutropenia and has become an indispensable therapy in various clinical settings. The development and approval of filgrastim biosimilars have expanded treatment options and improved accessibility, offered cost-effective alternatives while maintained comparable safety and efficacy. .
Keywords: Filgrastim, Bio-similar, Physicochemical, SDS-PAGE, HPLC.
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