Abstract
A biosimilar is a drug product that has been deemed to be highly similar to its off-patent reference product in terms of purity, molecular structure, and bioactivity. Approvals to such products are granted on the basis of unambiguous demonstration of “no clinically meaningful differences” between the reference and the intended biosimilar. For a successful biosimilar approval, establishing analytical and functional biosimilarity across all relevant critical quality attributes is an essential prerequisite. This critical activity is performed using a combination of orthogonal, high-resolution tools that can accurately quantitate the minor differences that exist. In this article, we review key findings from some of the recent biosimilarity assessments that we have published on biosimilars of granulocyte-colony-stimulating factor (G-CSF), insulin glargine, rituximab, and trastuzumab.
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