Z 8 % \nindustry over the next decade, mainly because of the current market penetration of\nbiologics and the need to provide payers cost savings over the originator therapeutics.\nLegislative support and regulatory guidance have facilitated their entry into pharmacy\nformularies of the future. Unlike small molecule generic drugs, biosimilars are\nheterogeneous proteins manufactured using cell-based systems of either microbial or\nmammalian origin. The use of living systems to manufacture drugs raises challenges\nin terms of product characterization and therapeutic equivalence to the innovator\nprotein therapeutic. In this article, we share some lessons learned from developing\nand validating pharmacokinetic and immunogenicity assays that support preclinical\nand clinical comparative studies for the development of biosimilars.
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